Clinical trial NCT06896903: Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
Official title: Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ANOCA - Angina With Non-obstructive Coronary Arteries
INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
Keywords: Coronary Reactivity Testing
Intracoronary Nitroglycerine
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older
2. Patient being evaluated for ANOCA or INOCA
3. Clinical suspicion for angina
4. Patient should be able to comply with the protocol.
5. Provide written informed consent before study participation.

Exclusion Criteria:

1. Existing coronary artery disease
2. Previous percutaneous interventions within the coronaries
3. Current use (within 48 hours) of long-acting nitrate therapies
4. Current use (within 48 hours) of PDE-5 inhibitors (sildenafil, tadalafil)
5. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
6. Children below 18 years, prisoners, pregnant people and patients who are unable to provide consent are excluded.

Primary outcomes:
measure: Assessment of CFR by CRT before and after nitrates
timeFrame: Intra op
Secondary outcomes:
measure: IMR, HMR, Pd/Pa, RRR, RFR, and transit times before and after nitrates.
timeFrame: Intra op
Other outcomes:
Locations:
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
Study officials:
References:
citation: Smilowitz NR, Prasad M, Widmer RJ, Toleva O, Quesada O, Sutton NR, Lerman A, Reynolds HR, Kesarwani M, Savage MP, Sweeny JM, Janaszek KB, Barseghian El-Farra A, Holoshitz N, Park K, Albadri A, Blair JA, Jeremias A, Kearney KE, Kobayashi Y, Miner SES, Samuels BA, Shah SM, Taqueti VR, Wei J, Fearon WF, Moses JW, Henry TD, Tremmel JA; Microvascular Network (MVN). Comprehensive Management of ANOCA, Part 2-Program Development, Treatment, and Research Initiatives: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Sep 19;82(12):1264-1279. doi: 10.1016/j.jacc.2023.06.044.
citation: Samuels BA, Shah SM, Widmer RJ, Kobayashi Y, Miner SES, Taqueti VR, Jeremias A, Albadri A, Blair JA, Kearney KE, Wei J, Park K, Barseghian El-Farra A, Holoshitz N, Janaszek KB, Kesarwani M, Lerman A, Prasad M, Quesada O, Reynolds HR, Savage MP, Smilowitz NR, Sutton NR, Sweeny JM, Toleva O, Henry TD, Moses JW, Fearon WF, Tremmel JA; Microvascular Network (MVN). Comprehensive Management of ANOCA, Part 1-Definition, Patient Population, and Diagnosis: JACC State-of-the-Art Review. J Am Coll Cardiol. 2023 Sep 19;82(12):1245-1263. doi: 10.1016/j.jacc.2023.06.043.
citation: Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.