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RecruitingNCT00823563noCADUpdated Jun 5, 2025

Evaluation of Patients With Non-obstructive Coronary Arteries

An observational study in Chest Pain and Ischemia, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Stanford University · Observational

From the registry’s dates

  • Started Jun 2007; still recruiting 19 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

This is a prospective registry of patients with chest pain, chest discomfort, breathlessness who do not have a blockage in their heart artery. This condition is known as angina/ischemia and non-obstructive coronary arteries (ANOCA/INOCA). The purpose of this registry is to help us understand the prevalence, causes of these conditions, identify effective diagnostic strategy, and long term outcome in this patient population.

Patients will undergo comprehensive invasive evaluation including coronary angiography, intravascular imaging, and physiologic measurements as a standard of care. Details regarding the participant's angiogram, endothelial function testing, microvascular testing, intravascular ultrasound, and myocardial bridge testing, if performed, will be entered into a research database.

Participants may be contacted by email or phone periodically for follow-up information, such as surveys, an update on medical history, and/or a check on their medical status or symptoms. We anticipate gathering these data at 6 months, 1 year, 3 years, 5 years, and 10 years, and every 5 years thereafter following their enrollment.

The overall objective of this registry study is to identify specific endotypes of ANOCA by invasive evaluation and study long term outcome.

Specific goals include:

  1. Describe the prevalence of the following ANOCA endotypes: endothelial dysfunction, microvascular dysfunction, vasospastic angina, myocardial bridging (MB), and other disorders of coronary physiology, and non-cardiac chest pain;
  2. Characterize the natural history and outcomes of patients with ANOCA and determine variables associated with major adverse cardiovascular events
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Conditions studied

  • Chest Pain
  • Ischemia

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In context

Chest Pain

381 studies on the registry are indexed under Chest Pain; 66 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 500 across 163 observational studies indexed under Chest Pain.

Browse Chest Pain studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. Patient referred for elective coronary angiography because of a reasonable clinical suspicion of coronary ischemia.
  2. 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).

Exclusion criteria

Exclusion Criteria:

  1. Asymptomatic (such as a pre-op cath)
  2. Status-post heart transplant
  3. Age \<18
  4. Renal insufficiency (creatinine >1.5)
  5. Presence of an acute coronary syndrome (STEMI or NSTEMI), Tako-tsubo, an abnormal ejection fraction (EF\<55%), cardiogenic shock, or recent VT/VF
  6. Presence of another likely explanation of chest pain, such as pulmonary hypertension or aortic stenosis
  7. History of adverse reaction to any of the medications being used (acetylcholine, nitroglycerin, adenosine, or heparin)
  8. Currently taking vasoactive medication (such as nitroglycerin)
  9. Inability to provide an informed consent, including an inability to speak, read, or understand English, Spanish, Chinese, Farsi, Japanese, Korean, Russian, or Vietnamese
  10. 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
  11. Participation in another study (with the exception of the Stanford Gene-PAD study)
  12. A potentially vulnerable subject (including minors, pregnant women, economically and educationally disadvantaged, decisionally impaired, and homeless people)
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes

Interventions

  • Procedure30 cc blood draw
  • ProcedureIntravascular ultrasound (IVUS)
  • ProcedureCoronary pressure/flow wire testing
  • ProcedureCoronary pressure/flow testing: Acetycholine challenge
  • ProcedureProcedure: Coronary pressure/flow testing: Nitroglycerin challenge
  • ProcedureProcedure: Procedure: Coronary pressure/flow testing: Adenosine challenge
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What researchers measure

Primary outcomes

  1. 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

    Time frame: Day of procedure (study day one)

  2. Number of participants with major adverse cardiovascular events (MACE)

    MACE - death, heart attack, revascularization, stroke

    Time frame: 15 years

Secondary outcomes

  1. Change in Seattle angina questionnaire score

    Scores range from 0 - 100, higher score means better outcome

    Time frame: Baseline, 6 months, 1 year, 3 year, every 5 years thereafter

  2. Number of patients with cardiovascular rehospitalization

    Time frame: 15 years

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Study locations

1 of 1 sites recruiting
  • Stanford University School of Medicine
    Stanford, California 94305, United States
    • Vedant S Pargaonkar, MD · Sub investigator
    • Alan CY Yeung, MD · Sub investigator
    Recruiting
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References and documents

Publications

  • Tremmel JA, Yeung AC. Ischemic heart disease in women: an appropriate time to discriminate. Rev Cardiovasc Med. 2007 Spring;8(2):61-8. PubMed 17603424 ↗
  • 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. PubMed 28675696 ↗
  • 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. PubMed 30527992 ↗
  • 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. PubMed 25712205 ↗
  • 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. PubMed 25457408 ↗
  • 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. PubMed 26947385 ↗
  • 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. PubMed 31706871 ↗
  • 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. PubMed 31416658 ↗
  • 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. PubMed 28921787 ↗
  • 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. PubMed 27745841 ↗
  • 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. PubMed 28690285 ↗
  • 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. PubMed 27098967 ↗
  • 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. PubMed 32220488 ↗
  • 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. PubMed 26404195 ↗
  • 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. PubMed 32279562 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00823563
Lead sponsor
Stanford University
Responsible party
Jennifer A Tremmel, MD, MS (Associate Professor, Stanford University) — Principal investigator
First posted
Jan 15, 2009
Start date
Jun 2007
Primary completion
Jun 2047 (estimated)
Completion
Jun 2047 (estimated)
Last update
Jun 5, 2025

Study contacts

Vedant Pargaonkar, MD
Contact
vedantsp@stanford.edu
(650) 498-1195
Jennifer A Tremmel, MD, MS
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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