RecruitingNCT00823563

Evaluation of Patients With Non-obstructive Coronary Arteries

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


Sponsor

Stanford University

Enrollment

2,000 participants

Start Date

Jun 1, 2007

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria12

  • 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)

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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

Locations(1)

Stanford University School of Medicine

Stanford, California, United States

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NCT00823563


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