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Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women (MVD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00663520
First received: April 18, 2008
Last updated: July 22, 2011
Last verified: April 2008
History of Changes
  Purpose

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.


Condition
Microvascular Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with chest pain and "Clean" heart vessels
2
Healthy volunteers

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Fifty non-smoking women, between 45 and 75 years of age, with chest pain will be referred to this study by clinicians at OHSU. The control group will be fifty non-smoking women with no cardiac symptoms, matched with the study group by age and risk factors. Flyers and other advertisements may be used to recruit both the study group and the control group. Criteria for exclusion from the study are pregnancy, allergy to any component in the drugs used in the study, severe asthma, known disease of the heart vessels or heart valves, active infection, cancer, uncontrolled hypertension, kidney disease and current smoking status.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663520

Contacts
Contact: Diana Rinkevich, MD 503-494-7400 rinkevichd@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Diana Rinkevich, MD            
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Diana Rinkevich, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Diana Rinkevich, MD, OHSU
ClinicalTrials.gov Identifier: NCT00663520     History of Changes
Other Study ID Numbers: Study #3631
Study First Received: April 18, 2008
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Cardiac disease
vascular dysfunction
women
chest pain
echocardiography

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013