- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184155
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
June 1, 2023 updated by: Thomas Jefferson University
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Melissa McCarey, MPH
- Phone Number: 215-503-7417
- Email: melissa.mccarey@jefferson.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
Contact:
- Melissa McCarey, MPH
- Phone Number: 215-503-7417
- Email: melissa.mccarey@jefferson.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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.
|
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.
|
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)
Time Frame: 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
|
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)
Time Frame: 6-8 hours post procedure
|
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)
Time Frame: 12-18 hours post procedure
|
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
Time Frame: 30 Days following procedure
|
Incidence of myocardial infarction, rehospitalization, or mortality
|
30 Days following procedure
|
Major Adverse Cardiac Event
Time Frame: I year following procedure
|
Incidence of myocardial infarction, rehospitalization, or mortality
|
I year following procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Savage, MD, Thomas Jefferson University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimated)
June 2, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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