Myocardial InfarctionNCT01953029
Mechanisms of Myocardial Infarction in Women With Non Obstructive Coronary Artery Disease
An observational study of Myocardial Infarction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The objective of our work to determine the mechanisms of myocardial infarction in women without obstructive coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- cardiac imajing
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Oct 2018
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with myocardial infarction
Who may be able to join
- 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. -
Who cannot join
- Women with troponin elevation caused by other causes -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam Heath Care Campus
Haifa, 9602
Miry Blich, MD, 972-4-854-3478, m_blich@rambam.health.gov.il
Miry Blich, MD
About this study
The objective of our work to determine the mechanisms of myocardial infarction in women without obstructive coronary artery disease.
Read the 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.
- Conditions
- Myocardial Infarction
- Being tested
- cardiac imajing
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac imajingProcedure or surgery
Cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| non obstructive coronary disease | non obstructive coronary disease Receives: Procedure: cardiac imajing |
What is being measured
The primary outcome is the main question the study is designed to answer.
MORTALITY
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miry Blich MD, Rambam Health Care Campus
- Investigators
- Miry Blich, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953029
- Sponsor's protocol ID
- 0541-12-RMB
- Status last verified
- Sep 2013
- First submitted
- 23 Sep 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Myocardial Infarction in Women With Non Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01953029
- Acronym / sponsor ID
- 0541-12-RMB
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 30 Sep 2013 (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 objective of our work to determine the mechanisms of myocardial infarction in women without obstructive coronary artery disease.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non obstructive coronary disease | – | Procedure: cardiac imajingnon obstructive coronary disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with myocardial infarction
Key inclusion criteria (3 listed)
- 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. -
Key exclusion criteria (1 listed)
- Women with troponin elevation caused by other causes -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac imajingCardiac MRI | Procedure or surgery | non obstructive coronary disease |
Primary outcome
MORTALITY
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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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.
Miry Blich, MD principal investigator
Rambam Health Care Campus
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 Myocardial Infarction, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miry Blich, MD (972-4-8543478, m_blich@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MORTALITY (time frame: 1 YEAR). 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 30 Sep 2013.