Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Allopurinol to Improve Heart Function in Individuals With Dilated Cardiomyopathy

NCT00281255

Cardiovascular Diseases Cardiomyopathy, Dilated Heart Diseases +1 more

WITHDRAWN PHASE1/PHASE2

Oral Nicorandil in ST Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

NCT04632121

Nicorandil

UNKNOWN

Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents

NCT04703751

Dilated Cardiomyopathy

UNKNOWN NA

Simvastatin Therapy in Patients With Dilated Cardiomyopathy.

NCT03775070

Dilated Cardiomyopathy

COMPLETED PHASE2

Oral Nicorandil for Prevention of No Reflow Phenomenon in Anterior STEMI Patients Undergoing PPCI

NCT07138508

No Reflow Phenomenon Anterior STEMI

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double blind, placebo controlled, study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Nicardipine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Sterile Saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No