Back to resultsPrevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
Primary Purpose
Coronary Artery Disease
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nicardipine
Sterile Saline
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Nicardipine, Percutaneous Coronary Intervention, Coronary Artery Disease
Eligibility 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
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intracoronary Nicardipine
Sterile Saline
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Post-Procedure myocardial Infarction (PMI)
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Post-Procedure myocardial Infarction (PMI)
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Major Adverse Cardiac Event
Incidence of myocardial infarction, rehospitalization, or mortality
Major Adverse Cardiac Event
Incidence of myocardial infarction, rehospitalization, or mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03184155
Brief Title
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
Official Title
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2025 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Nicardipine, Percutaneous Coronary Intervention, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blind, placebo controlled, study
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracoronary Nicardipine
Arm Type
Experimental
Arm Description
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.
Arm Title
Sterile Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicardipine
Intervention Description
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
Intervention Name(s)
Sterile Saline
Intervention Description
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 Measure Information:
Title
Change in Index of Microcirculatory Resistance (IMR)
Description
IMR is an intracoronary artery pressure measurement obtained during cardiac catheterization, and is a reliable indicator of microvascular dysfunction
Time Frame
From the start of the PCI procedure to immediately following the PCI procedure
Secondary Outcome Measure Information:
Title
Post-Procedure myocardial Infarction (PMI)
Description
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Time Frame
6-8 hours post procedure
Title
Post-Procedure myocardial Infarction (PMI)
Description
PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.
Time Frame
12-18 hours post procedure
Title
Major Adverse Cardiac Event
Description
Incidence of myocardial infarction, rehospitalization, or mortality
Time Frame
30 Days following procedure
Title
Major Adverse Cardiac Event
Description
Incidence of myocardial infarction, rehospitalization, or mortality
Time Frame
I year following procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa McCarey, MPH
Phone
215-503-7417
Email
melissa.mccarey@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Savage, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa McCarey, MPH
Phone
215-503-7417
Email
melissa.mccarey@jefferson.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine
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