Clinical trial NCT00663520: Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
Official title: Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microvascular Dysfunction
Keywords: Cardiac disease
vascular dysfunction
women
chest pain
echocardiography
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
timeFrame: 2008-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Diana Rinkevich, MD
role: PRINCIPAL_INVESTIGATOR
References: