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NCT Number: NCT00823563

Evaluation of Patients With Non-obstructive Coronary Arteries

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Alan CY Yeung, MD

SUB_INVESTIGATOR

Vedant S Pargaonkar, MD

SUB_INVESTIGATOR

About this study

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:

  • 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;
  • Characterize the natural history and outcomes of patients with ANOCA and determine variables associated with major adverse cardiovascular events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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)

Treatment and study plan

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

Primary outcomes

  1. Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque

    Time frame: Day of procedure (study day one)

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

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

    Time frame: 15 years

    MACE - death, heart attack, revascularization, stroke

Secondary outcomes

  1. Change in Seattle angina questionnaire score

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

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

  2. Number of patients with cardiovascular rehospitalization

    Time frame: 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Vedant Pargaonkar, MD

CONTACT

[email protected]

(650) 498-1195

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Evaluation of Patients With Angina in the Absence of Obstructive Coronary Artery Disease

Acronym: noCAD

Important dates

Study start
2007
Primary completion
2047
Study completion
2047
First posted
Jan 15, 2009
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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