Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction
2 other identifiers
interventional
65
1 country
1
Brief Summary
The broad objective is to advance our understanding of both in vivo anatomical and functional changes that are present in the coronary arteries in women who have an acute coronary syndrome. Specific focus will be placed on the age of the women as there may be distinct differences in younger women (\< 50 years) given the marked increase in mortality in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedApril 15, 2011
April 1, 2011
3.8 years
December 21, 2007
April 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plaque Virtual Histology
Performed during PCI
Secondary Outcomes (3)
Endothelial Progenitor Cells
Collected immediately pre PCI
Microvascular function in the noninfarct related vessel
Assessed immediately post PCI
Virtual Histology in noninfarct related vessel
Assessed immediately post PCI
Study Arms (1)
1
ACTIVE COMPARATORGender comparison
Interventions
Eligibility Criteria
You may qualify if:
- Age of 18 years or older
- Acute coronary syndrome defined as at least two of the following:
- A) an elevated cardiac biomarker (troponin or CK-MB), B) new or dynamic ECG changes in at least 2 contiguous standard electrocardiographic leads of ST depression \> 1 mm or ST elevation of \>1 mm or T-wave inversions, C) chest pain or discomfort of at least 15 minutes duration, D) a new wall motion abnormality by echocardiography
- Patient who is undergoing coronary angiography
- Physician planning to perform IVUS for treatment of the infarct-related vessel
You may not qualify if:
- Creatinine \> 2.0 mg/dL (most recent)
- Hemodynamically unstable patients (systolic blood pressure \< 90 mmHg or heart rate \> 110 beats/ minute or presence of an intra-aortic balloon pump)
- Coronary revascularization (percutaneously or surgically) within 6 months
- The use of chronic immunosuppressive agents
- No target lesion was found at the time of cardiac catheterization that will be percutaneously intervened upon (the patient must undergo percutaneous coronary intervention)
- Inability to give informed consent
- Pregnant or lactating women
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia M. Best, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
March 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 15, 2011
Record last verified: 2011-04