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Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184155
Recruitment Status : Not yet recruiting
First Posted : June 12, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Nicardipine Drug: Sterile Saline Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blind, placebo controlled, study
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Major Adverse Cardiac Event [ Time Frame: 30 Days following procedure ]
    Incidence of myocardial infarction, rehospitalization, or mortality

  4. Major Adverse Cardiac Event [ Time Frame: I year following procedure ]
    Incidence of myocardial infarction, rehospitalization, or mortality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184155


Contacts
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Contact: Melissa McCarey, MPH 215-503-7417 melissa.mccarey@jefferson.edu
Contact: Thomas Salerno, RN 215-503-8954 thomas.salerno@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Contact: Melissa McCarey, MPH    215-503-7417    melissa.mccarey@jefferson.edu   
Contact: Thomas Salerno, RN    215-503-8954    thomas.salerno@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Michael Savage, MD Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03184155    
Other Study ID Numbers: 17D.172
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Thomas Jefferson University:
Nicardipine
Percutaneous Coronary Intervention
Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Nicardipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents