Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT03184155
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicardipine — 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 — 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

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Apr 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Index of Microcirculatory Resistance (IMR) [ Time Frame: From the start of the PCI procedure to immediately following the PCI procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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By research site
Thomas Jefferson University· Philadelphia, PA

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