Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI

• Sponsor: University College, London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03726164
• Collaborator: University College London Hospitals (Other), Surrey and Sussex Healthcare NHS Trust (Other)
• Enrollment: 626
• Arms: 2
• Duration (Months): 78

Study Details

Study Description

Brief Summary

This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.

Condition or Disease	Intervention/Treatment	Phase
Post Procedural Myocardial Infarction	Device: Remote Conditioning; Device: Sham protocol	N/A

Detailed Description

Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study.

Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography.

This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection.

Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups.

Primary end point

Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.

Study Design

• Study Type: Interventional
• Actual Enrollment: 626 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Study Investigating the Cardioprotective Benefits of Remote Ischaemic Postconditioning in Patients Presenting With Non ST Elevation Acute Coronary Syndromes Undergoing In-hospital Percutaneous Coronary Intervention
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Remote Conditioning group Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.	Device: Remote Conditioning; A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.; Other Names: RIC
Placebo Comparator: Control Group Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.	Device: Sham protocol; An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.; Other Names: Control

Outcome Measures

Primary Outcome Measures

1. Peri-Procedural Myocardial Injury [24 hours post PCI]

   Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T>3x 99th percentile upper reference limit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

Exclusion Criteria:

• Known renal failure

• Known liver disease

• Peripheral vascular disease involving upper limbs

• Inability to consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University College, London
• University College London Hospitals
• Surrey and Sussex Healthcare NHS Trust

Investigators

• Study Director: Derek M Yellon, PhD, FACC, University College, London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT03726164
• Other Study ID Numbers: 05/0138
• First Posted: Oct 31, 2018
• Last Update Posted: Dec 1, 2020
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Myocardial Infarction; Infarction

Study Results

Participant Flow

Arm/Group Title	Remote Conditioning Group	Control Group
Arm/Group Description	Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure. Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.	Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group. Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Period Title: Overall Study
STARTED	310	316
COMPLETED	99	119
NOT COMPLETED	211	197

Baseline Characteristics

Arm/Group Title	Remote Conditioning Group	Control Group	Total
Arm/Group Description	Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure. Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.	Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group. Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.	Total of all reporting groups
Overall Participants	99	119	218
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.1 (11.3)	63.7 (11.0)	62.9 (11.1)
Sex: Female, Male (Count of Participants)
Female	14 14.1%	30 25.2%	44 20.2%
Male	85 85.9%	89 74.8%	174 79.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	99 100%	119 100%	218 100%

Outcome Measures

1. Primary Outcome

Title	Peri-Procedural Myocardial Injury
Description	Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T>3x 99th percentile upper reference limit
Time Frame	24 hours post PCI

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Remote Conditioning Group	Control Group
Arm/Group Description	Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure. Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.	Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group. Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Measure Participants	99	119
Count of Participants [Participants]	23 23.2%	29 24.4%

Adverse Events

Arm/Group Title	Remote Conditioning Group		Control Group
Arm/Group Description	Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure. Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.		Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group. Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
All Cause Mortality
	Remote Conditioning Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/119 (0%)
Serious Adverse Events
	Remote Conditioning Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/119 (0%)
Other (Not Including Serious) Adverse Events
	Remote Conditioning Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/119 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.