We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00663520
Recruitment Status : Unknown
Verified April 2008 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : April 22, 2008
Last Update Posted : July 25, 2011
Information provided by:

Study Description
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.

Condition or disease
Microvascular Dysfunction

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
Study Start Date : January 2008
Estimated Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Groups and Cohorts

Women with chest pain and "Clean" heart vessels
Healthy volunteers

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663520

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

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
Principal Investigator: Diana Rinkevich, MD Oregon Health and Science University
More Information

Responsible Party: Diana Rinkevich, MD, OHSU
ClinicalTrials.gov Identifier: NCT00663520     History of Changes
Other Study ID Numbers: Study #3631
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: April 2008

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases