AMICI: Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infarction

• Sponsor: Mesoblast, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01781390
• Collaborator: (none)
• Enrollment: 106
• Arms: 3
• Actual Duration (Months): 96.9

Study Details

Study Description

Brief Summary

This was a double-blind, randomized, placebo-controlled study that was designed to enroll a total of 225 participants with de novo anterior wall acute ST-segment elevation myocardial infarction (STEMI) due to a lesion of the left anterior descending coronary artery undergoing percutaneous coronary intervention (PCI). Eligible participants were to be enrolled and undergo revascularization of the culprit left anterior descending (LAD) coronary artery. The interventional procedure included as dose ranging assessment of intracoronary (IC) delivery of MPC or placebo infused into the stented coronary artery. This study compared two doses of MPCs and a placebo control group. Study participants were randomly assigned in 1:1:1 fashion to receive either 12.5 Million or 25 Million MPCs or placebo (saline). Initially, each group was designed to have approximately 75 patients per treatment group. The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population.

The Primary Objective of the study was to determine the safety and feasibility of IC infusion of investigational MPCs in this acute STEMI population. Feasibility of the infusion of the investigational agent was assessed by measurement of thrombolysis in myocardial infarction (TIMI) flow and perfusion (1) immediately prior to, (2) during (after approximately 50% of total investigational agent volume infused) and (3) following the investigational agent infusion after successful PCI and stenting. There was no evidence of clinically important coronary microvascular obstruction related to infusion of the investigational agent.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction	Other: Placebo; Biological: Mesenchymal Precursor Cells (MPC) 12.5 M; Biological: Mesenchymal Precursor Cells (MPC) 25 M	Phase 2

Detailed Description

This was a prospective, double-blind, randomized, placebo-controlled study that was designed to enroll approximately 225 participants with de novo anterior STEMI due to a lesion involving the proximal-mid LAD coronary artery who undergo primary PCI at approximately 45 clinical study sites. However, due to difficulty in consenting participants and operationalizing the protocol under the emergency environment of an acute STEMI, it became clear that a major protocol amendment would be required. Accordingly, the protocol was adjusted to randomize 105 participants (35 per treatment group) at 25 clinical study sites. This 53% reduction in participants from the original protocol allowed preliminary evaluations of safety and feasibility.

Potential participants who were in the midst of experiencing an acute anterior wall STEMI, where increased time to coronary revascularization is known to correlate with the extent of subsequent myocardial necrosis, were approached by a study site investigator prior to PCI to determine the participant's interest to participate in a stem cell investigational trial. This required the patient to sign an informed consent permitting both the PCI procedure and participation in the trial. Participants who agreed to participate in the AMICI study and had a successful and uneventful PCI and stenting of the culprit LAD lesion performed were then randomized to one of the three treatment groups. The randomization and treatment assignment were obtained using an interactive voice-response system (IVRS/interactive web response system [IWRS]). The following stratification for duration of cardiac ischemia was performed to ensure balanced randomization across the treatment groups:

• ≤2 hours

• 2 hours to ≤6 hours

• 6 to ≤12 hours

Eligible participants received intracoronary delivery of the assigned treatment infused via a microcatheter into the stented culprit artery.

After approximately 50% of the intracoronary infusion of investigational treatment was completed, an angiographic determination of coronary flow was performed. The following guidelines were used to determine if the remaining investigational agent should be infused:

The study infusion should have been continued if TIMI 2 or TIMI 3 flow was present in the absence of ALL of the following;

• Sustained hypotension not responsive to fluid administration;

• Clinical signs/symptoms indicating an acute cerebrovascular event;

• Re-elevation of ST-segments if previously resolved with PCI;

• Onset of the participant's symptoms of myocardial ischemia unresponsive to appropriate interventions;

• Two episodes of sustained ventricular tachycardia (VT)/ventricular fibrillation (VF) requiring cardioversion (infusion can continue if a single episode of sustained VT/VF requiring cardioversion occurred).

Feasibility of the infusion of the investigational agent was assessed by measurement of TIMI flow and perfusion (1) immediately prior to, (2) during (after approximately 50% of total investigational agent volume infused) and (3) following the investigational agent infusion after successful PCI and stenting. There was no evidence of clinically important coronary microvascular obstruction related to infusion of the investigational agent.

If, for any reason, the site investigator withdrew a randomized participant prior to infusion of the investigational agent, the reason for early termination and data from the screening visit were entered into the eCRF by the study site. The participant did not remain in the study. If for any reason, a participant's study infusion was halted due to safety considerations, the participant remained in the study. A participant who prematurely withdrew from the study remained in the study for long-term safety follow-up.

Evaluation for safety was performed for up to 24 months post infusion for all non-Swedish sites. Participants enrolled in Sweden who consented for additional follow-up underwent safety assessments at 36, 48, and 60 months post-infusion of investigational agent. All participants were to have cardiac imaging using cardiac magnetic resonance imaging [cMRI] and 2D-echocardiography, Holter monitoring, clinical evaluations, and laboratory testing as outlined in the study protocol.

An independent Data Monitoring Safety Board (DSMB) reviewed all relevant acute peri-procedural data, serious adverse events (SAE), other adverse events (AE), and efficacy data (if requested) periodically until participant enrolment was closed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Double-Blind, Randomized, Placebo-controlled Clinical Trial of Intracoronary Infusion of Mesenchymal Precursor Cells (MPC) in the Treatment of Patients With ST-Elevation Myocardial Infarction
• Actual Study Start Date: Mar 11, 2013
• Actual Primary Completion Date: Apr 6, 2021
• Actual Study Completion Date: Apr 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants received matching-placebo solution 2 milliliters per minute (mL/min) infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.	Other: Placebo; Matching placebo solution for infusion.
Experimental: Mesenchymal Precursor Cells (MPC) 12.5 M Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.	Biological: Mesenchymal Precursor Cells (MPC) 12.5 M; MPC 12.5 M solution for infusion.
Experimental: Mesenchymal Precursor Cells (MPC) 25 M Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.	Biological: Mesenchymal Precursor Cells (MPC) 25 M; MPC 25 M solution for infusion.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Up to approximately 8 years]

   Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Clinical symptoms consistent with acute myocardial infarct (AMI) (pain, etc.) for a maximum of 12 hours from onset of symptoms to percutaneous coronary intervention (PCI).

• De Novo anterior AMI.

• Successful revascularization of the culprit lesion.

Key Exclusion Criteria:

• Prior AMI, known cardiomyopathy, or hospital admission for heart failure (HF).

• Significant valvular disease.

• Need for other interventional or surgical procedure to treat heart disease (planned or scheduled).

• Cardiogenic shock or hemodynamic instability within 24 hours of randomization.

• Prior PCI to LAD.

• Pacemaker, ICD (Implantable Cardioverter Defibrillator), or any other contra-indication for cardiac MRI.

• Prior or current participation in any stem cell study or any other investigational trial in the past 30 days.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mesoblast, Inc.

Investigators

• Study Director: Fred Grossman, DO, Mesoblast, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 4, 2017

More Information

Publications

None provided.

• Responsible Party: Mesoblast, Inc.
• ClinicalTrials.gov Identifier: NCT01781390
• Other Study ID Numbers: ANG.AMI-IC001; 2010-020497-41
• First Posted: Feb 1, 2013
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Mesoblast, Inc.: Acute Myocardial Infarction; STEMI; Heart Attack; AMI; Stem Cells
• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	Placebo	Mesenchymal Precursor Cells (MPC) 12.5 M	Mesenchymal Precursor Cells (MPC) 25 M
Arm/Group Description	Participants received matching-placebo solution 2 milliliter per minute (mL/min) infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.	Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.	Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
Period Title: Overall Study
STARTED	35	35	36
COMPLETED	32	28	32
NOT COMPLETED	3	7	4

Baseline Characteristics

Arm/Group Title	Placebo	Mesenchymal Precursor Cells (MPC) 12.5 M	Mesenchymal Precursor Cells (MPC) 25 M	Total
Arm/Group Description	Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.	Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.	Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.	Total of all reporting groups
Overall Participants	34	34	35	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (9.79)	60.7 (13.11)	57.6 (12.12)	59.8 (11.76)
Sex: Female, Male (Count of Participants)
Female	7 20.6%	2 5.9%	8 22.9%	17 16.5%
Male	27 79.4%	32 94.1%	27 77.1%	86 83.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.9%	1 2.9%	0 0%	2 1.9%
Not Hispanic or Latino	33 97.1%	33 97.1%	35 100%	101 98.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 2.9%	0 0%	0 0%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	33 97.1%	33 97.1%	34 97.1%	100 97.1%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 2.9%	1 2.9%	2 1.9%
Left Ventricular (LV) End-systolic Volume (LVESV) as Assessed by Cardiac MRI (milliliter (ml)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milliliter (ml)]	85.544 (34.8935)	91.728 (30.4476)	92.163 (33.1251)	89.821 (32.7025)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description	Safety measure: An AE is any unfavorable and unintended sign, symptom, or disease, whether or not related to the investigational product. A TEAE was defined as any AE with onset post study drug treatment. An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important.
Time Frame	Up to approximately 8 years

Outcome Measure Data

Analysis Population Description

The safety set included all participants who were randomly assigned to a treatment at screening and received treatment. Overall number analyzed is the participants available for analyses.

Arm/Group Title	Placebo	Mesenchymal Precursor Cells (MPC) 12.5 M	Mesenchymal Precursor Cells (MPC) 25 M
Arm/Group Description	Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 min including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.	Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (2.5x10^5 MPCs/min) on Day 0.	Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 min including line flush (5.0x10^5 MPCs/min) on Day 0.
Measure Participants	34	34	35
TEAEs	28 82.4%	30 88.2%	31 88.6%
SAEs	14 41.2%	16 47.1%	14 40%

Adverse Events

Time Frame	Up to approximately 8 years
Adverse Event Reporting Description	The safety set included all participants who were randomly assigned to a treatment at screening and received treatment.
Arm/Group Title	Placebo		Mesenchymal Precursor Cells (MPC) 12.5 M		Mesenchymal Precursor Cells (MPC) 25 M
Arm/Group Description	Participants received matching-placebo solution 2 mL/min infused Intracoronary for 60 mins including line flush [0 Mesenchymal Precursor Cells (MPCs)/min] on Day 0.		Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (2.5x10^5 MPCs/min) on Day 0.		Participants received MPC 12.5 solution 2 mL/min infused Intracoronary for 60 mins including line flush (5.0x10^5 MPCs/min) on Day 0.
All Cause Mortality
	Placebo		Mesenchymal Precursor Cells (MPC) 12.5 M		Mesenchymal Precursor Cells (MPC) 25 M
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		2/34 (5.9%)		2/35 (5.7%)
Serious Adverse Events
	Placebo		Mesenchymal Precursor Cells (MPC) 12.5 M		Mesenchymal Precursor Cells (MPC) 25 M
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/34 (41.2%)		16/34 (47.1%)		14/35 (40%)
Blood and lymphatic system disorders
Iron deficiency anaemia	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Cardiac disorders
Cardiac failure	2/34 (5.9%)		3/34 (8.8%)		1/35 (2.9%)
Angina pectoris	2/34 (5.9%)		0/34 (0%)		1/35 (2.9%)
Acute coronary syndrome	0/34 (0%)		1/34 (2.9%)		1/35 (2.9%)
Angina unstable	1/34 (2.9%)		1/34 (2.9%)		0/35 (0%)
Atrioventricular block complete	2/34 (5.9%)		0/34 (0%)		0/35 (0%)
Cardiac ventricular thrombosis	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
Coronary artery disease	1/34 (2.9%)		1/34 (2.9%)		0/35 (0%)
Coronary artery stenosis	1/34 (2.9%)		0/34 (0%)		1/35 (2.9%)
Acute myocardial infarction	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Arteriospasm coronary	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Atrial fibrillation	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Cardiac failure acute	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Cardiac failure chronic	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Cardiogenic shock	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Myocardial infarction	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Ventricular tachycardia	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
General disorders
Non-cardiac chest pain	1/34 (2.9%)		1/34 (2.9%)		3/35 (8.6%)
Chest pain	1/34 (2.9%)		0/34 (0%)		1/35 (2.9%)
Multiple organ dysfunction syndrome	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Vascular stent thrombosis	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Infections and infestations
Pneumonia	1/34 (2.9%)		2/34 (5.9%)		0/35 (0%)
Urosepsis	0/34 (0%)		1/34 (2.9%)		1/35 (2.9%)
Diaphragmatic hernia gangrenous	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Intervertebral discitis	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Respiratory tract infection	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Sepsis	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Injury, poisoning and procedural complications
Accidental overdose	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Head injury	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Overdose	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Tibia fracture	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Wound complication	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Metabolism and nutrition disorders
Hypovolaemia	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
B-cell lymphoma	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Gastrointestinal stromal tumour	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Lymphoma	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Thyroid adenoma	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Nervous system disorders
Syncope	1/34 (2.9%)		1/34 (2.9%)		0/35 (0%)
Cerebrovascular accident	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Ischaemic stroke	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Migraine with aura	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Transient ischaemic attack	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Psychiatric disorders
Depression	1/34 (2.9%)		1/34 (2.9%)		0/35 (0%)
Acute psychosis	1/34 (2.9%)		0/34 (0%)		0/35 (0%)
Anxiety	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Renal and urinary disorders
Acute kidney injury	0/34 (0%)		0/34 (0%)		1/35 (2.9%)
Ureterolithiasis	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Vascular disorders
Hypertension	0/34 (0%)		1/34 (2.9%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Mesenchymal Precursor Cells (MPC) 12.5 M		Mesenchymal Precursor Cells (MPC) 25 M
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/34 (76.5%)		33/34 (97.1%)		31/35 (88.6%)
Blood and lymphatic system disorders
Anaemia	2/34 (5.9%)		2/34 (5.9%)		0/35 (0%)
Iron deficiency anaemia	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
Cardiac disorders
Ventricular tachycardia	1/34 (2.9%)		3/34 (8.8%)		6/35 (17.1%)
Bradycardia	1/34 (2.9%)		2/34 (5.9%)		2/35 (5.7%)
Atrial fibrillation	1/34 (2.9%)		2/34 (5.9%)		2/35 (5.7%)
Palpitations	0/34 (0%)		3/34 (8.8%)		1/35 (2.9%)
Pericarditis	0/34 (0%)		1/34 (2.9%)		3/35 (8.6%)
Arteriospasm coronary	2/34 (5.9%)		0/34 (0%)		0/35 (0%)
Ventricular extrasystoles	0/34 (0%)		0/34 (0%)		2/35 (5.7%)
Cardiac failure	1/34 (2.9%)		1/34 (2.9%)		3/35 (8.6%)
Angina pectoris	2/34 (5.9%)		3/34 (8.8%)		1/35 (2.9%)
Cardiac ventricular thrombosis	1/34 (2.9%)		4/34 (11.8%)		0/35 (0%)
Eye disorders
Vision blurred	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
Gastrointestinal disorders
Diarrhoea	4/34 (11.8%)		3/34 (8.8%)		5/35 (14.3%)
Nausea	1/34 (2.9%)		5/34 (14.7%)		3/35 (8.6%)
Constipation	1/34 (2.9%)		5/34 (14.7%)		1/35 (2.9%)
Vomiting	2/34 (5.9%)		2/34 (5.9%)		3/35 (8.6%)
Abdominal pain	1/34 (2.9%)		2/34 (5.9%)		2/35 (5.7%)
Gastrooesophageal reflux disease	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
General disorders
Pyrexia	5/34 (14.7%)		2/34 (5.9%)		3/35 (8.6%)
Chest pain	2/34 (5.9%)		1/34 (2.9%)		4/35 (11.4%)
Fatigue	2/34 (5.9%)		3/34 (8.8%)		1/35 (2.9%)
Catheter site haematoma	1/34 (2.9%)		2/34 (5.9%)		1/35 (2.9%)
Oedema peripheral	0/34 (0%)		2/34 (5.9%)		2/35 (5.7%)
Multiple organ dysfunction syndrome	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
Non-cardiac chest pain	2/34 (5.9%)		5/34 (14.7%)		2/35 (5.7%)
Infections and infestations
Lower respiratory tract infection	0/34 (0%)		2/34 (5.9%)		3/35 (8.6%)
Influenza	2/34 (5.9%)		1/34 (2.9%)		1/35 (2.9%)
Nasopharyngitis	3/34 (8.8%)		0/34 (0%)		1/35 (2.9%)
Respiratory tract infection	0/34 (0%)		1/34 (2.9%)		3/35 (8.6%)
Urinary tract infection	1/34 (2.9%)		3/34 (8.8%)		0/35 (0%)
Upper respiratory tract infection	0/34 (0%)		0/34 (0%)		2/35 (5.7%)
Pneumonia	0/34 (0%)		2/34 (5.9%)		1/35 (2.9%)
Injury, poisoning and procedural complications
Post procedural haematoma	4/34 (11.8%)		1/34 (2.9%)		0/35 (0%)
Contusion	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
Investigations
Blood triglycerides increased	0/34 (0%)		0/34 (0%)		2/35 (5.7%)
Metabolism and nutrition disorders
Hypokalaemia	2/34 (5.9%)		1/34 (2.9%)		1/35 (2.9%)
Dyslipidaemia	0/34 (0%)		0/34 (0%)		2/35 (5.7%)
Musculoskeletal and connective tissue disorders
Musculoskeletal pain	1/34 (2.9%)		4/34 (11.8%)		1/35 (2.9%)
Back pain	0/34 (0%)		1/34 (2.9%)		4/35 (11.4%)
Muscle spasms	2/34 (5.9%)		1/34 (2.9%)		1/35 (2.9%)
Musculoskeletal chest pain	0/34 (0%)		2/34 (5.9%)		2/35 (5.7%)
Myalgia	2/34 (5.9%)		1/34 (2.9%)		0/35 (0%)
Pain in extremity	1/34 (2.9%)		0/34 (0%)		2/35 (5.7%)
Nervous system disorders
Dizziness	4/34 (11.8%)		8/34 (23.5%)		5/35 (14.3%)
Headache	2/34 (5.9%)		1/34 (2.9%)		2/35 (5.7%)
Lethargy	1/34 (2.9%)		3/34 (8.8%)		1/35 (2.9%)
Dizziness postural	1/34 (2.9%)		2/34 (5.9%)		0/35 (0%)
Presyncope	1/34 (2.9%)		2/34 (5.9%)		0/35 (0%)
Psychiatric disorders
Anxiety	1/34 (2.9%)		3/34 (8.8%)		1/35 (2.9%)
Insomnia	1/34 (2.9%)		1/34 (2.9%)		2/35 (5.7%)
Renal and urinary disorders
Dysuria	0/34 (0%)		0/34 (0%)		3/35 (8.6%)
Lower urinary tract symptoms	0/34 (0%)		2/34 (5.9%)		0/35 (0%)
Rales	2/34 (5.9%)		1/34 (2.9%)		0/35 (0%)
Dysphonia	2/34 (5.9%)		0/34 (0%)		0/35 (0%)
Reproductive system and breast disorders
Erectile dysfunction	2/34 (5.9%)		0/34 (0%)		2/35 (5.7%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/34 (5.9%)		8/34 (23.5%)		2/35 (5.7%)
Cough	2/34 (5.9%)		2/34 (5.9%)		5/35 (14.3%)
Epistaxis	2/34 (5.9%)		0/34 (0%)		1/35 (2.9%)
Vascular disorders
Hypotension	2/34 (5.9%)		4/34 (11.8%)		1/35 (2.9%)
Hypertension	1/34 (2.9%)		2/34 (5.9%)		3/35 (8.6%)
Peripheral coldness	1/34 (2.9%)		4/34 (11.8%)		1/35 (2.9%)

Limitations/Caveats

Originally, 225 de novo anterior STEMI participants were to undergo primary PCI. However, due to difficulty in consenting participants and operationalizing protocol under emergency conditions associated with acute STEMI, a major protocol amendment was required. The protocol was adjusted to randomize 105 participants. This 53% reduction in participants from the original protocol allowed preliminary evaluations of safety and feasibility.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publications (abstracts, posters or presentations) must be presented to Publication Steering Committee for review prior to submission or public display and are not allowed prior to the publication of the primary manuscript, or eighteen (18) months from the conclusion of the Study. PI shall provide Sponsor a copy of any proposed public disclosure at least 30 days prior to submission. Sponsor may ask PI to delay the disclosure for a maximum of 60 days to file proprietary protection.