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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intra op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bonnie Ostergren | Contact | 469-814-4181 | Bonnie.Ostergren@bswhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Plano | Recruiting | Plano | Texas | 75093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37704316 | Background | 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. | |
| 37704315 |
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| 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. |
| 31504439 | 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. |