Comprehensive Management of ANOCA, Part 2-Program Development, Treatment, and Research Initiatives: JACC State-of-the-Art Review.
Nathaniel R Smilowitz, Megha Prasad, R Jay Widmer...
https://pubmed.ncbi.nlm.nih.gov/37704316Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06896903
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
Led by Baylor Research Institute · Updated on 2026-05-05
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and related measurements in patients with angina but without significant coronary artery disease. This prospective, single-arm study involves patients undergoing coronary angiography for angina with non-obstructive coronary artery disease (ANOCA or INOCA). The goal is to understand changes in these coronary function measures before and after intracoronary nitroglycerin administration. Participants will undergo coronary reactivity testing (CRT) in the left anterior descending and right coronary arteries. First, measurements such as CFR, IMR, distal coronary to aortic pressure ratio (Pd/Pa), transit times, resting full-cycle ratio (RFR), fractional flow reserve (FFR), and resistive reserve ratio (RRR) will be taken without intracoronary nitrates. Then, a dose of 200-500 mcg of intracoronary nitroglycerin will be administered and the same measurements repeated to observe changes. During the study, approximately 50 patients will be monitored during their cardiac catheterization procedure. Data will be collected intraoperatively to compare coronary function variables before and after nitrate administration. Researchers will analyze primary outcomes focusing on CFR changes and secondary outcomes including IMR, Pd, Pa, RRR, and transit times. The study aims to provide detailed insight into coronary microcirculatory function in this patient population.
CONDITIONS
Brief Title
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 or older
- Being evaluated for angina with non-obstructive coronary arteries (ANOCA) or ischemia with non-obstructive coronary artery disease (INOCA)
- Clinical suspicion for angina
- Able to comply with the study protocol
- Provide written informed consent before participation
You will not qualify if you...
- Existing coronary artery disease
- Previous percutaneous coronary interventions
- Use of long-acting nitrate therapies within 48 hours
- Use of PDE-5 inhibitors (e.g., sildenafil, tadalafil) within 48 hours
- Any condition posing significant hazard as judged by the investigator
- Children under 18 years, prisoners, pregnant people, or those unable to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Treatment
Duration - Single day procedure
Participants undergo coronary reactivity testing first without intracoronary nitrates followed by administration of intracoronary nitrates and repeat testing to assess coronary function.
1 procedure visit (in-person) in the cardiac catheterization laboratory
Trial Site Locations
Total: 1 location
1
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Actively Recruiting
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Research Team
B
Bonnie Ostergren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Published Research Related To This Trial
Comprehensive Management of ANOCA, Part 1-Definition, Patient Population, and Diagnosis: JACC State-of-the-Art Review.
Bruce A Samuels, Samit M Shah, R Jay Widmer...
https://pubmed.ncbi.nlm.nih.gov/377043152019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes.
Juhani Knuuti, William Wijns, Antti Saraste...
https://pubmed.ncbi.nlm.nih.gov/31504439