Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT06896903
Brief 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.
Study:
NCT06896903
Study Brief:
Protocol Section:
NCT06896903