Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

Microvascular Dysfunction Clinical Trial

— MVD  

Official title:

Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663520
• Other study ID #: Study #3631
• Status: Completed
• First received: April 18, 2008
• Last updated: April 16, 2018
• Start date: January 2008
• Est. completion date: February 2014

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Not Available

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Microvascular Dysfunction

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women	Data collection	2008-2014