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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00587002
Collaborator
(none)
65
1
1
45
1.4

Study Details

Study Description

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 Phase
  • Procedure: IVUS
N/A

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 Design

Study Type:
Interventional
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 :
Mar 1, 2007
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Gender comparison

Procedure: IVUS
Intravascular ultrasound with virtual histology

Outcome Measures

Primary Outcome Measures

  1. Plaque Virtual Histology [Performed during PCI]

Secondary Outcome Measures

  1. Endothelial Progenitor Cells [Collected immediately pre PCI]

  2. Microvascular function in the noninfarct related vessel [Assessed immediately post PCI]

  3. Virtual Histology in noninfarct related vessel [Assessed immediately post PCI]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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:

  1. 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

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Patricia M. Best, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00587002
Other Study ID Numbers:
  • 07-001023
  • Epi-Plaque
First Posted:
Jan 7, 2008
Last Update Posted:
Apr 15, 2011
Last Verified:
Apr 1, 2011
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2011