Evaluating sex differences in causes of chest pain

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

This study is trying to find out why women and men with normal heart arteries experience chest pain differently, to help improve how we test and treat these symptoms in women.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT00823563 on ClinicalTrials.gov

What this trial studies

This research evaluates the underlying causes of chest pain in individuals with normal coronary arteries as seen on angiograms. The study focuses on identifying diffuse atherosclerosis and dysfunction in the coronary endothelium and microcirculation, particularly comparing findings between women and men. By conducting blood draws and specialized tests like intravascular ultrasound and coronary pressure/flow testing, the study aims to uncover potential pathophysiological differences that may contribute to chest pain in women. The ultimate goal is to improve testing and treatment strategies for women experiencing these symptoms.

Who should consider this trial

Good fit: Ideal candidates include individuals referred for elective coronary angiography due to suspected coronary ischemia and who experience angina or anginal equivalents.

Not a fit: Patients who are asymptomatic, have a history of heart surgery, or have other conditions explaining their chest pain may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better diagnosis and treatment options for women suffering from chest pain with normal angiograms.

How similar studies have performed: While there is emerging evidence regarding sex differences in coronary pathophysiology, this specific comparative approach has not been extensively studied, making it a novel investigation.

Eligibility criteria

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)

Where this trial is running

Stanford, California

• Stanford University School of Medicine — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Jennifer A Tremmel, MD, MS — Stanford University
• Study coordinator: Vedant Pargaonkar, MD

Conditions Chest Pain; Ischemia