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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587002
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : April 15, 2011
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment
Myocardial Infarction Procedure: IVUS

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction
Study Start Date : March 2007
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Gender comparison
Procedure: IVUS
Intravascular ultrasound with virtual histology

Primary Outcome Measures :
  1. Plaque Virtual Histology [ Time Frame: Performed during PCI ]

Secondary Outcome Measures :
  1. Endothelial Progenitor Cells [ Time Frame: Collected immediately pre PCI ]
  2. Microvascular function in the noninfarct related vessel [ Time Frame: Assessed immediately post PCI ]
  3. Virtual Histology in noninfarct related vessel [ Time Frame: Assessed immediately post PCI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00587002

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Patricia M. Best, M.D. Mayo Clinic

Additional Information:
Responsible Party: Patricia Best, M.D., Mayo Clinic Identifier: NCT00587002     History of Changes
Other Study ID Numbers: 07-001023
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Keywords provided by Mayo Clinic:
Acute Coronary Syndrome

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases