Heart Disease of the Small Arteries in Women and Men

NCT00573027 | Recruiting DMC

• 1 other identifier: IRB 8221
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

Brief Summary

Women suffer disproportionately than men from Cardiac Syndrome X ( chest pain in the absence of flow limiting coronary artery stenosis). Coronary microvascular disease is hypothesized to mediate chest pain in this syndrome. This disorder of the small heart vessels (arterioles) compared to the large vessels (arteries) is not diagnosed during routine heart catheterization. This results in delays in diagnosis, missed opportunities for treatment, and likely contributes to the increased death rate from coronary heart disease in women compared to men. Current testing for small vessel disease is performed in the cardiac catheterization laboratory using specialized testing and is not performed routinely. Accordingly, women with this condition are either falsely reassured, or misdiagnosed as another non-cardiac condition. Unnecessary healthcare costs related to re-hospitalization and repeat angiography are incurred, while women are often not initiated on appropriate lifesaving treatment. We and others have demonstrated in randomized controlled trials that therapies that target the endothelium, e.g. statins, ACE inhibitors, and exercise are effective in this condition. Majority of women with Cardiac Syndorme X go undiagnosed. Recent studies have shown significant increased health care costs, morbidity and mortality related to this disease. It is becoming more important to further characterize this group of patients and we hope to do that with our study.

Conditions

Heart Disease

Keywords

microvascular dysfunction; Microvascular

Outcome Measures

Primary Outcomes (1)

• noninvasive Peripheral Artery Tonometry (PAT) testing and Cardiac Magnetic Resonance (CMR) imaging for the outcome of coronary endothelial dysfunction

  120 minutes

Secondary Outcomes (1)

• clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing

  60 minutes

Study Arms (1)

Single Arm

OTHER

1. fill out baseline demographic and health/medical history questionnaires, CV risk factors, reasons of diagnosis of ischemia, information of coronary artery, and medication use 2. undergo clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory (Appendix); 3. undergo noninvasive Peripheral Artery Tonometry (PAT) testing (Appendix); 4. undergo clinically indicated Cardiac Magnetic Resonance (CMR) imaging (Appendix) to detect subendocardial ischemia (if indicated and referred by the treating physician). The three tests (heart catheterization with adenosine coronary flow reserve testing, acetylcholine provocative vasomotor testing during heart catheterization, cardiac MRI) are performed for standard care. 5. have blood and urine testing. 6. fill out health questionnaires 7. be followed prospectively 6-week, 6-month, and annually for clinical status

Procedure: noninvasive tests

Interventions

noninvasive tests PROCEDURE

clinically indicated coronary angiography with adenosine coronary flow reserve measurement and acetylcholine provocative testing in the cardiac catheterization laboratory; Peripheral Artery Tonometry (PAT) testing; Cardiac Magnetic Resonance (CMR) imaging.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and men with signs and symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing) or microvascular angina (MVA) which is defined as angina and ischemic ECG changes without organic obstructive stenosis or epicardial spasm of the coronary arteries
• No obstructive coronary artery disease performed within the previous 24 months (\<50% luminal obstruction in one or more coronary arteries on angiography).
• Age \> 18 years old
• Competent to give informed consent

You may not qualify if:

• Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
• Acute coronary syndrome (defined by the ACC/AHA criteria, Braunwald 2000),
• Primary valvular heart disease clearly indicating the need for valve repair or replacement;
• Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
• Prior or planned percutaneous coronary intervention or CABG or prior acute MI in prior 30 days;
• Prior non-cardiac illness with an estimated life expectancy \<4 years;
• Unable to give informed consent;
• Chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
• Contraindications to adenosine or Regadenoson (Lexiscan)
• Women and men with intermediate coronary stenoses (\>20% but \<50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated IVUS testing based on the judgment of the operator; those determined to have flow FFR or obstructing stenosis will be excluded from the overall study.
• Heart failure (NYHA Class III or IV on treatment)
• LV dysfunction (ejection fraction \<40%)
• Documented obstructive myocardiopathy

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• C.Noel Bairey-Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbra Streisand Women's Heart Center

CONTACT

310-423-9666

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: November 1, 2005
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)