- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01953029
Mechanisms of Myocardial Infarction in Women With Non Obstructive Coronary Artery Disease
September 25, 2013 updated by: Miry Blich MD, Rambam Health Care Campus
The objective of our work to determine the mechanisms of myocardial infarction in women without obstructive coronary artery disease.
Study Overview
Detailed Description
Cardiovascular disease is the leading cause of death for women.
Acute coronary syndrome (ACS) is usually characterized by a sudden erosion of the endothelial wall or rupture of a plaque.However, women with ACS are less likely than men to have either classic symptoms or obstructive coronary artery disease but paradoxically have a worse prognosis.
Different data from the literature indicate that there may be different pathophysiological mechanisms, afflicting men and women somewhat differently.Between 5% and 30% of patients with ACS undergoing coronary angiography are found to have non visible or non obstructive coronary disease (NOCD).
This is 2-3 times more common in women than in men.
Several pathogenetic mechanism of myocardial infarction (MI) in the absence of obstructive coronary artery disease (OCD) have been postulated, including among others atherosclerosis with plaque disruption that does not lead to luminal occlusion ,endothelial dysfunction, vasospasm , distal microembolization and microvascular dysfunction.
However the data are extremely limited.
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haifa, Israel, 9602
- Rambam Heath Care Campus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with myocardial infarction
Description
Inclusion Criteria:
- Women ≥ 18 years old, not pregnant
- with acute non ST elevation myocardial infarction (admitted within 12 hours from beginning of symptoms)
- who are candidates for coronary arteriography during the hospitalization. -
Exclusion Criteria:
*Women with troponin elevation caused by other causes -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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non obstructive coronary disease
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Cardiac MRI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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MORTALITY
Time Frame: 1 YEAR
|
1 YEAR
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Miry Blich, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
September 23, 2013
First Submitted That Met QC Criteria
September 25, 2013
First Posted (Estimate)
September 30, 2013
Study Record Updates
Last Update Posted (Estimate)
September 30, 2013
Last Update Submitted That Met QC Criteria
September 25, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0541-12-RMB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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