Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT00823563

Conditions

Chest Pain

Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

30 cc blood draw

Intravascular ultrasound (IVUS)

Coronary pressure/flow wire testing

Coronary pressure/flow testing: Acetycholine challenge

Procedure: Coronary pressure/flow testing: Nitroglycerin challenge

Study Details

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

Study ID

NCT00823563

Start date

Jun, 2007

Status verified date

Jun, 2025

Completion date

Jun, 2047

Anticipated

Primary completion date

Jun, 2047

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

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)

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

30 cc blood draw

Intravascular ultrasound (IVUS)

Coronary pressure/flow wire testing

Coronary pressure/flow testing: Acetycholine challenge

Procedure: Coronary pressure/flow testing: Nitroglycerin challenge

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

Primary outcome measure

  • Sex Differences in Endothelial Dysfunction, Microvascular Dysfunction, and Diffuse Plaque [ Time Frame: Day of procedure (study day one) ]
  • Number of participants with major adverse cardiovascular events (MACE) [ Time Frame: 15 years ]

Central Contacts and Locations

Central contacts

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

More Information

Sponsor

Stanford University

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-06-05.