ANOCA - Angina With Non-obstructive Coronary ArteriesCRT-NITRONCT06896903
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
A study testing Coronary reactivity testing with and without nitrates in people with ANOCA - Angina With Non-obstructive Coronary Arteries and INOCA (Ischemia With Non Obstructive Coronary Artery Disease), run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANOCA - Angina With Non-obstructive Coronary Arteries, INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
- What is being tested?
- Coronary reactivity testing with and without nitrates
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
Bonnie Ostergren, 469-814-4181, Bonnie.Ostergren@bswhealth.org
Sarah Hale, 469-814-4845, Sarah.Hale@bswhealth.org
About this study
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.
Read the 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.
- Conditions
- ANOCA - Angina With Non-obstructive Coronary Arteries, INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
- Being tested
- Coronary reactivity testing with and without nitrates
- Keywords
- Coronary Reactivity Testing, Intracoronary Nitroglycerine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary reactivity testing with and without nitratesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Coronary reactivity testing with and without nitrates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra op
Secondary outcomes (1)
IMR, HMR, Pd/Pa, RRR, RFR, and transit times before and after nitrates.
The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates.
Measured: Intra op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start21 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ANOCA - Angina With Non-obstructive Coronary ArteriesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896903
- Sponsor's protocol ID
- 025-193
- Acronym
- CRT-NITRO
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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, 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.
PubMed 37704316Samuels 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.
PubMed 37704315Knuuti 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.
PubMed 31504439
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing
- ClinicalTrials.gov ID
- NCT06896903
- Acronym / sponsor ID
- CRT-NITRO / 025-193
- Conditions
- ANOCA - Angina With Non-obstructive Coronary Arteries, INOCA (Ischemia With Non Obstructive Coronary Artery Disease)
- Keywords
- Coronary Reactivity Testing, Intracoronary Nitroglycerine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Reactivity Testing with and without intracoronary nitroglycerine | Experimental | Diagnostic Test: Coronary reactivity testing with and without nitratesCRT 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary reactivity testing with and without nitratesCRT 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. | Diagnostic test | Coronary Reactivity Testing with and without intracoronary nitroglycerine |
Primary outcome
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.
1 secondary outcome
IMR, HMR, Pd/Pa, RRR, RFR, and transit times before and after nitrates.
Time frame: Intra op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 37704316Smilowitz 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.
- Background: PubMed 37704315Samuels 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.
- Background: PubMed 31504439Knuuti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary reactivity testing with and without nitrates in people with ANOCA - Angina With Non-obstructive Coronary Arteries and INOCA (Ischemia With Non Obstructive Coronary Artery Disease), run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonnie Ostergren (469-814-4181, Bonnie.Ostergren@bswhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of CFR by CRT before and after nitrates (time frame: Intra op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06896903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.