Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Sponsor

Thomas Jefferson University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03184155

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Nicardipine Drug: Sterile Saline	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized double blind, placebo controlled, studyRandomized double blind, placebo controlled, study

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intracoronary Nicardipine 200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement.	Drug: Nicardipine 200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI
Placebo Comparator: Sterile Saline Injection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement.	Drug: Sterile Saline Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI

Arm

Intervention/Treatment

Experimental: Intracoronary Nicardipine

200 mcg intracoronary injection of nicardipine prior to PCI, with potential for additional 100 mcg nicardipine before stent placement, balloon post-dilation, and before post-PCI IMR measurement.

Drug: Nicardipine

200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI

Placebo Comparator: Sterile Saline

Injection of sterile saline prior to PCI, with potential for additional saline injections before stent placement, balloon post-dilation, and before post-PCI IMR measurement.

Drug: Sterile Saline

Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI

Outcome Measures

Primary Outcome Measures

Change in Index of Microcirculatory Resistance (IMR) [From the start of the PCI procedure to immediately following the PCI procedure]
IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction

Secondary Outcome Measures

Post-Procedure myocardial Infarction (PMI) [6-8 hours post procedure]
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Post-Procedure myocardial Infarction (PMI) [12-18 hours post procedure]
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Major Adverse Cardiac Event [30 Days following procedure]
Incidence of myocardial infarction, rehospitalization, or mortality
Major Adverse Cardiac Event [I year following procedure]
Incidence of myocardial infarction, rehospitalization, or mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consenting adults age > 18 years
Patients with stable coronary disease, stable angina, and/or objective evidence of myocardial ischemia OR
Target vessel lesion with > 50% stenosis treated by PCI

Exclusion Criteria:

Patients presenting with ST elevation myocardial infarction
Complete total occlusion of the vessel
Unprotected left main disease
Presentation with acute coronary syndrome and actively rising troponin
Contraindication to adenosine (advanced heart blocks, bronchospasm, HSN to the drug)
Known hypersensitivity to nicardipine
Severe aortic stenosis
Left Ventricular dysfunction with ejection fraction less than 30%
Hemodynamically unstable defined as systolic blood pressure < 90 mmHg and not responding to IV fluids
Significant chronic renal insufficiency (Glomerular filtration rate [GFR] <30)
Unwilling or unable to provide informed consent