Evaluation of Patients With Non-obstructive Coronary Arteries

NCT00823563 | Recruiting DMC

• 1 other identifier: 51267
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with angina and non-obstructive CAD are common within clinical practice, but remain a challenge with regard to diagnosis and treatment. When these patients undergo a comprehensive evaluation at the time of invasive coronary angiography, occult coronary abnormalities are frequently found. We hope to learn the overall prevalence and presentation of these occult coronary abnormalities and its long term outcome in this patient population.

Conditions

Chest Pain; Ischemia

Outcome Measures

Primary Outcomes (2)

• Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque

  This outcome is to measure the prevalence of angina and non-obstructive coronary arteries (ANOCA) endotypes

  Day of procedure (study day one)

• Number of participants with major adverse cardiovascular events (MACE)

  MACE - death, heart attack, revascularization, stroke

  15 years

Secondary Outcomes (2)

• Change in Seattle angina questionnaire score

  Baseline, 6 months, 1 year, 3 year, every 5 years thereafter

• Number of patients with cardiovascular rehospitalization

  15 years

Interventions

30 cc blood draw PROCEDURE

Intravascular ultrasound (IVUS) PROCEDURE

Coronary pressure/flow wire testing PROCEDURE

Coronary pressure/flow testing: Acetycholine challenge PROCEDURE

Procedure: Coronary pressure/flow testing: Nitroglycerin challenge PROCEDURE

Procedure: Procedure: Coronary pressure/flow testing: Adenosine challenge PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women and men with angina who have been referred for an elective coronary angiogram because of a reasonable clinical suspicion of coronary ischemia.

You may qualify if:

• Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia.
• Presence of angina or an anginal equivalent (including chest, back, shoulder, arm, neck, jaw discomfort, or shortness of breath brought on by physical exertion, emotional stress, or certain times of day/month).

You may not qualify if:

• Asymptomatic (such as a pre-op cath)
• Status-post heart transplant
• Age \<18
• Renal insufficiency (creatinine \>1.5)
• Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal ejection fraction (EF\<55%), cardiogenic shock, or recent VT/VF
• Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis
• History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin)
• Currently taking vasoactive medication (such as nitroglycerin)
• Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese
• A hearing impairment that won't allow for a typical verbal conversation or a visual impairment that won't allow for reading of the written consent
• Participation in another study (with the exception of the Stanford Gene-PAD study)
• A potentially vulnerable subject (including minors, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

Related Publications (15)

• Tremmel JA, Yeung AC. Ischemic heart disease in women: an appropriate time to discriminate. Rev Cardiovasc Med. 2007 Spring;8(2):61-8.

  PMID: 17603424 BACKGROUND

• Rogers IS, Tremmel JA, Schnittger I. Myocardial bridges: Overview of diagnosis and management. Congenit Heart Dis. 2017 Sep;12(5):619-623. doi: 10.1111/chd.12499. Epub 2017 Jul 3.

  PMID: 28675696 BACKGROUND

• Pargaonkar VS, Kobayashi Y, Kimura T, Schnittger I, Chow EKH, Froelicher VF, Rogers IS, Lee DP, Fearon WF, Yeung AC, Stefanick ML, Tremmel JA. Accuracy of non-invasive stress testing in women and men with angina in the absence of obstructive coronary artery disease. Int J Cardiol. 2019 May 1;282:7-15. doi: 10.1016/j.ijcard.2018.10.073. Epub 2018 Oct 23.

  PMID: 30527992 BACKGROUND

• Lee BK, Lim HS, Fearon WF, Yong AS, Yamada R, Tanaka S, Lee DP, Yeung AC, Tremmel JA. Invasive evaluation of patients with angina in the absence of obstructive coronary artery disease. Circulation. 2015 Mar 24;131(12):1054-60. doi: 10.1161/CIRCULATIONAHA.114.012636. Epub 2015 Feb 20.

  PMID: 25712205 BACKGROUND

• Tremmel JA, Schnittger I. Myocardial bridging. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2178-9. doi: 10.1016/j.jacc.2014.07.993. Epub 2014 Nov 10. No abstract available.

  PMID: 25457408 BACKGROUND

• Tremmel JA. To Define Is to Limit: Is That Good or Bad When it Comes to Chest Pain? JACC Cardiovasc Interv. 2016 Mar 28;9(6):562-4. doi: 10.1016/j.jcin.2016.02.002. Epub 2016 Mar 2. No abstract available.

  PMID: 26947385 BACKGROUND

• Schnittger I, Boyd JH, Tremmel JA. A Step Back in the Diagnosis and Management of Myocardial Bridging. Ann Thorac Surg. 2020 Jun;109(6):1950. doi: 10.1016/j.athoracsur.2019.09.051. Epub 2019 Nov 7. No abstract available.

  PMID: 31706871 BACKGROUND

• Parikh RV, Pargaonkar V, Ball RL, Kobayashi Y, Kimura T, Yeung AC, Cooke JP, Tremmel JA. Asymmetric dimethylarginine predicts impaired epicardial coronary vasomotion in patients with angina in the absence of obstructive coronary artery disease. Int J Cardiol. 2020 Jan 15;299:7-11. doi: 10.1016/j.ijcard.2019.07.062. Epub 2019 Jul 19.

  PMID: 31416658 BACKGROUND

• Nishikii-Tachibana M, Pargaonkar VS, Schnittger I, Haddad F, Rogers IS, Tremmel JA, Wang PJ. Myocardial bridging is associated with exercise-induced ventricular arrhythmia and increases in QT dispersion. Ann Noninvasive Electrocardiol. 2018 Mar;23(2):e12492. doi: 10.1111/anec.12492. Epub 2017 Sep 18.

  PMID: 28921787 BACKGROUND

• Boyd JH, Pargaonkar VS, Scoville DH, Rogers IS, Kimura T, Tanaka S, Yamada R, Fischbein MP, Tremmel JA, Mitchell RS, Schnittger I. Surgical Unroofing of Hemodynamically Significant Left Anterior Descending Myocardial Bridges. Ann Thorac Surg. 2017 May;103(5):1443-1450. doi: 10.1016/j.athoracsur.2016.08.035. Epub 2016 Oct 13.

  PMID: 27745841 BACKGROUND

• Forsdahl SH, Rogers IS, Schnittger I, Tanaka S, Kimura T, Pargaonkar VS, Chan FP, Fleischmann D, Tremmel JA, Becker HC. Myocardial Bridges on Coronary Computed Tomography Angiography - Correlation With Intravascular Ultrasound and Fractional Flow Reserve. Circ J. 2017 Nov 24;81(12):1894-1900. doi: 10.1253/circj.CJ-17-0284. Epub 2017 Jul 7.

  PMID: 28690285 BACKGROUND

• Yamada R, Tremmel JA, Tanaka S, Lin S, Kobayashi Y, Hollak MB, Yock PG, Fitzgerald PJ, Schnittger I, Honda Y. Functional Versus Anatomic Assessment of Myocardial Bridging by Intravascular Ultrasound: Impact of Arterial Compression on Proximal Atherosclerotic Plaque. J Am Heart Assoc. 2016 Apr 20;5(4):e001735. doi: 10.1161/JAHA.114.001735.

  PMID: 27098967 BACKGROUND

• Pargaonkar VS, Tremmel JA, Schnittger I, Khandelwal A. Effect of ranolazine on symptom and quality of life in patients with angina in the absence of obstructive coronary artery disease: A case control study. Int J Cardiol. 2020 Jun 15;309:8-13. doi: 10.1016/j.ijcard.2020.02.014. Epub 2020 Feb 6.

  PMID: 32220488 BACKGROUND

• Kobayashi Y, Fearon WF, Honda Y, Tanaka S, Pargaonkar V, Fitzgerald PJ, Lee DP, Stefanick M, Yeung AC, Tremmel JA. Effect of Sex Differences on Invasive Measures of Coronary Microvascular Dysfunction in Patients With Angina in the Absence of Obstructive Coronary Artery Disease. JACC Cardiovasc Interv. 2015 Sep;8(11):1433-1441. doi: 10.1016/j.jcin.2015.03.045.

  PMID: 26404195 BACKGROUND

• Pargaonkar VS, Lee JH, Chow EKH, Nishi T, Ball RL, Kobayashi Y, Kimura T, Lee DP, Stefanick ML, Fearon WF, Yeung AC, Tremmel JA. Dose-Response Relationship Between Intracoronary Acetylcholine and Minimal Lumen Diameter in Coronary Endothelial Function Testing of Women and Men With Angina and No Obstructive Coronary Artery Disease. Circ Cardiovasc Interv. 2020 Apr;13(4):e008587. doi: 10.1161/CIRCINTERVENTIONS.119.008587. Epub 2020 Apr 13.

  PMID: 32279562 BACKGROUND

Related Links

• Women's Heart Health at Stanford homepage

MeSH Terms

Conditions

Chest Pain; Ischemia

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jennifer A Tremmel, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vedant Pargaonkar, MD

CONTACT

(650) 498-1195; vedantsp@stanford.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: June 1, 2007
• Primary Completion (Estimated): June 1, 2047
• Study Completion (Estimated): June 1, 2047
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (1)