Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

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.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Nicardipine; Drug: Sterile Saline

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Michael Savage, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Nicardipine
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Nicardipine
• Other Study ID Numbers: 17D.172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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