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Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction

Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00587002
Enrollment
65
Registered
2008-01-07
Start date
2007-03-31
Completion date
2010-12-31
Last updated
2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

Acute Coronary Syndrome, Women

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.

Detailed description

The hypothesis of the current study is that plaque erosion and microvascular dysfunction are key features responsible for the increased peri-MI mortality in young women. In order to test this hypothesis the following specific aims are proposed using a special intravascular ultrasound technique called virtual histology and microvascular function (effect of intracoronary adenosine on coronary blood flow) in patients coming to the cardiac catheterization laboratory with an acute MI: 1. To determine if plaque rupture or plaque erosion is more prevalent in young women (\<50 years) compared with older women (≥ 50 years) and men in the development of an acute MI 2. To determine if inflammatory mediators of plaque rupture are higher in older women and men with an acute MI compared with younger women 3. To determine if microvascular function is abnormal in young women undergoing percutaneous coronary revascularization with an acute MI compared to older women and men 4. To determine if alterations exist in the number and function of EPCs in young women (\<50 years) compared with older women (≥ 50 years) and men who have had an acute MI and to determine the association with microvascular function

Interventions

PROCEDUREIVUS

Intravascular ultrasound with virtual histology

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Plaque Virtual HistologyPerformed during PCI

Secondary

MeasureTime frame
Endothelial Progenitor CellsCollected immediately pre PCI
Microvascular function in the noninfarct related vesselAssessed immediately post PCI
Virtual Histology in noninfarct related vesselAssessed immediately post PCI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026