Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Early Phase 1

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: Sterile Saline; Drug: Nicardipine

• Registration Number: NCT03184155
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Study Start: 2025-12
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sterile Saline	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.
Intracoronary Nicardipine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	I year following procedure	Incidence of myocardial infarction, rehospitalization, or mortality

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States