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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587002
First received: December 21, 2007
Last updated: April 13, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention
Myocardial Infarction
 Procedure: IVUS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Differences in Epicardial Plaque and Microvascular Function in Women With an Acute Myocardial Infarction

Resource links provided by NLM:

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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Plaque Virtual Histology [ Time Frame: Performed during PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial Progenitor Cells [ Time Frame: Collected immediately pre PCI ] [ Designated as safety issue: No ]
  • Microvascular function in the noninfarct related vessel [ Time Frame: Assessed immediately post PCI ] [ Designated as safety issue: No ]
  • Virtual Histology in noninfarct related vessel [ Time Frame: Assessed immediately post PCI ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gender comparison
 Procedure: IVUS
Intravascular ultrasound with virtual histology

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587002

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

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Patricia Best, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587002     History of Changes
Other Study ID Numbers: 07-001023, Epi-Plaque
Study First Received: December 21, 2007
Last Updated: April 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Acute Coronary Syndrome
Women

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

ClinicalTrials.gov processed this record on May 19, 2013