Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 12:13 AM
Study NCT ID:
NCT06896903
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
Sponsor:
Baylor Research Institute
Organization:
Study Overview
Official Title:
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRT-NITRO
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: