Microvascular DysfunctionMVDNCT00663520
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
An observational study of Microvascular Dysfunction, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microvascular Dysfunction
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Women 45 to 75 years of age
Who cannot join
- 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
Show all 10Show fewer
- Uncontrolled hypertension
- Smoking
- Severe asthma
- Kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
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.
- Conditions
- Microvascular Dysfunction
- Keywords
- Cardiac disease, vascular dysfunction, women, chest pain, echocardiography
- Medical subject headings
- Heart Diseases, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with chest pain and "Clean" heart vessels | |
| 2 | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
Data collection
Measured: 2008-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular DysfunctionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Cannar, Oregon Health and Science University
- Investigators
- Diana Rinkevich, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663520
- Sponsor's protocol ID
- Study #3631
- Acronym
- MVD
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2008
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
- ClinicalTrials.gov ID
- NCT00663520
- Acronym / sponsor ID
- MVD / Study #3631
- Conditions
- Microvascular Dysfunction
- Keywords
- Cardiac disease, vascular dysfunction, women, chest pain, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with chest pain and "Clean" heart vessels |
| 2 | – | –Healthy volunteers |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women 45 to 75 years of age
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women
Time frame: 2008-2014
Data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No. No Plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Rinkevich, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microvascular Dysfunction, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elucidating the Role of Microvascular Dysfunction in Heart Disease in Women (time frame: 2008-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.