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Recruiting NCT06896903

Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing

No phase Interventional ANOCA - Angina With Non-obstructive Coronary Arteries INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coronary reactivity testing with and without nitrates.
Who it may be relevant to
Registry conditions: ANOCA - Angina With Non-obstructive Coronary Arteries, INOCA (Ischemia With Non Obstructive Coronary Artery Disease). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test Coronary reactivity testing with and without nitrates
    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.

Primary outcome measures

  • Assessment of CFR by CRT before and after nitrates [Time frame: Intra op]
Secondary outcome measures (1)
  • IMR, HMR, Pd/Pa, RRR, RFR, and transit times before and after nitrates. [Time frame: Intra op]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Baylor Scott & White The Heart Hospital - Plano — Plano

Publications

  • 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, Pa PMID 37704316
  • 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, Pa PMID 37704315
  • 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 PMID 31504439

Identifiers

NCT: NCT06896903 · 025-193

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗