NCT06896903

Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-arm, multi-center, prospective study will assess the coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and determinants thereof (transit time, Pa, Pd) in patients before and after intracoronary nitroglycerine.

Detailed description

This will be a single arm, multi-center, prospective interventional study. We will approach, consent, and enroll patients referred to the cardiac catheterization laboratory for coronary angiography for the indication of angina without obstructive coronary artery disease (CAD; lesions \<50%, fractional flow reserve (FFR) \>0.80, or non-hyperemic pressure index (RFR) \<0.89). Patients will undergo invasive assessment with CRT first without IC nitrates followed by a dose of 200-500 mcg of intracoronary nitrates and repeat CRT. Approximately 50 patients undergoing coronary angiography for evaluation of ANOCA or INOCA will be consented for this study. The primary outcome will be comparing the variables assessed by CRT with the primary outcome being CFR before and after nitroglycerin administration. The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates. These variables will be compared to one another using paired t-tests and generalized estimating equations.

Conditions

• ANOCA - Angina With Non-obstructive Coronary Arteries
• INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary reactivity testing with and without nitrates	CRT will be performed in the left and right coronary arteries. Measurements will be obtained in each of the coronaries first without intracoronary nitrates followed by a dose of 200-500 mcg of intracoronary nitrates and repeat measurements.

Timeline

• Start date: 2025-05-21
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-03-26
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study