Recruiting

Intracoronary Nitroglycerine

Sponsor:

Baylor Research Institute

Code:

NCT06896903

Conditions

ANOCA - Angina With Non-obstructive Coronary Arteries

INOCA (Ischemia With Non Obstructive Coronary Artery Disease)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary reactivity testing with and without nitrates

Study Details

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)

Study ID

NCT06896903

Start date

May 21, 2025

Status verified date

Mar, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Coronary Reactivity Testing with and without intracoronary nitroglycerine

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)

Interventions

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 measure

  • Assessment of CFR by CRT before and after nitrates [ Time Frame: Intra op ]

Central Contacts and Locations

Central contacts

Bonnie Ostergren

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

Locations

Baylor Scott & White The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Bonnie Ostergren

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

Sarah Hale

469-814-4845Sarah.Hale@bswhealth.org

More Information

Sponsor

Baylor Research Institute

Last update posted

May 5, 2026

Last verified

Mar, 2026

Keywords

  • Coronary Reactivity Testing
  • Intracoronary Nitroglycerine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-05-05.