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NCT Number: NCT06896903

Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Assessment of CFR by CRT before and after nitrates

    Time frame: Intra op

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

Secondary outcomes

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

    Time frame: Intra op

    The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates.

Study contacts

Contact information is provided by the study sponsor or research team.

Bonnie Ostergren

CONTACT

[email protected]

469-814-4181

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Acronym: CRT-NITRO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 26, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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