Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

Completed

• Conditions: Microvascular Dysfunction

• Registration Number: NCT00663520
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The purpose of this study is to determine if women with chest pain and "clean" heart blood vessels have impaired blood flow to the heart due to problems with the small blood vessels that provide blood and oxygen to the heart. Impairment in the small blood vessels will be tested using ultrasound pictures of the heart, called myocardial contrast echocardiography. Since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of the heart vessels using a dye containing iodine injected in the heart vessels, the problem may remain undiagnosed in women until the heart muscle becomes severely damaged.

A second purpose is to identify if there is a common trait in the population of women with this tiny blood vessel dysfunction, which will be investigated by checking blood levels of certain chemical and hormones related to heart disease. Finally, we would like to investigate the relationship between depression and stress, and heart disease. We will do this by measuring cortisol (a hormone that serves as a measure of stress) and administering questionnaires that help to identify depression and stress.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women 45 to 75 years of age

Exclusion Criteria

• Pregnancy
• Allergy to any component of the drugs: Definity®. Dipyridamole Aminophyllin or Iodine.
• Known coronary heart disease, significant valvular disease (valvular stenosis or insufficiency greater than moderate) left ventricular systolic dysfunction, congenital heart disease or cardiac shunt, pulmonary hypertension, moderate or severe asthma.
• Inability to reach the patient by mail, fax, e-mail or phone
• Active infection
• Malignancy
• Uncontrolled hypertension
• Smoking
• Severe asthma
• Kidney disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women	2008-2014	Data collection

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States