Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing

NCT06896903 | Recruiting FDA Device

• 1 other identifier: 025-193
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Coronary Reactivity Testing; Intracoronary Nitroglycerine

Outcome Measures

Primary Outcomes (1)

• Assessment of CFR by CRT before and after nitrates

  The primary outcome will be comparing the variables assessed by CRT with the primary outcome being CFR before and after nitroglycerin administration.

  Intra op

Secondary Outcomes (1)

• IMR, HMR, Pd/Pa, RRR, RFR, and transit times before and after nitrates.

  Intra op

Study Arms (1)

Coronary Reactivity Testing with and without intracoronary nitroglycerine

EXPERIMENTAL

CRT will be performed in the left anterior descending and right coronary arteries. The following measures 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: * Coronary flow reserve (CFR) (normal \> 2.0) * Index of microvascular resistance (IMR) (normal \<25) * Resting ratio of distal coronary pressure to aortic pressure (Pd/Pa) (normal \< 0.91) * Resting and hyperemic (using intravenous adenosine) transit time (Tm) * Resting full-cycle ratio (RFR) * Hyperemic (using intravenous adenosine) fractional flow reserve (FFR) * Resistive reserve ratio (RRR)

Diagnostic Test: Coronary reactivity testing with and without nitrates

Interventions

Coronary reactivity testing with and without nitrates DIAGNOSTIC_TEST

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.

Coronary Reactivity Testing with and without intracoronary nitroglycerine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Existing coronary artery disease
• Previous percutaneous interventions within the coronaries
• Current use (within 48 hours) of long-acting nitrate therapies
• Current use (within 48 hours) of PDE-5 inhibitors (sildenafil, tadalafil)
• 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.
• Children below 18 years, prisoners, pregnant people and patients who are unable to provide consent are excluded.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, 75093, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 37704316 BACKGROUND

• 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.

  PMID: 37704315 BACKGROUND

• 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.

  PMID: 31504439 BACKGROUND

Central Study Contacts

Bonnie Ostergren

CONTACT

469-814-4181; Bonnie.Ostergren@bswhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-03

Locations

US (1)