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

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.

Study Overview

• Status: Completed
• Conditions: Microvascular Dysfunction

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
2; Healthy volunteers
1; Women with chest pain and "Clean" heart vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women	Data collection	2008-2014

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Diana Rinkevich, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 18, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: chest pain; echocardiography; women; Cardiac disease; vascular dysfunction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Study #3631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No Plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No