Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

NCT ID: NCT00663520

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Microvascular Dysfunction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Women with chest pain and "Clean" heart vessels

No interventions assigned to this group

2

Healthy volunteers

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Cannar

Diana Rinkevich, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana Rinkevich, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

Study #3631

Identifier Type: -

Identifier Source: org_study_id