Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Coronary Artery Disease Clinical Trial

Official title:

Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03184155
• Other study ID #: 17D.172
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: December 2025
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From the start of the PCI procedure to immediately following the PCI procedure
Secondary	Post-Procedure myocardial Infarction (PMI)	PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.	6-8 hours post procedure
Secondary	Post-Procedure myocardial Infarction (PMI)	PMI is diagnosed by elevation of serum Troponin, 5 times the upper limit following a procedure.	12-18 hours post procedure
Secondary	Major Adverse Cardiac Event	Incidence of myocardial infarction, rehospitalization, or mortality	30 Days following procedure
Secondary	Major Adverse Cardiac Event	Incidence of myocardial infarction, rehospitalization, or mortality	I year following procedure