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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

IVUS

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Acute Coronary Syndrome, Women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Arm Description

Gender comparison

Outcomes

Primary Outcome Measures

Plaque Virtual Histology

Secondary Outcome Measures

Endothelial Progenitor Cells

Microvascular function in the noninfarct related vessel

Virtual Histology in noninfarct related vessel

Full Information

NCT ID

NCT00587002

First Posted

December 21, 2007

Last Updated

April 13, 2011

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00587002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. 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.

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: 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 To determine if inflammatory mediators of plaque rupture are higher in older women and men with an acute MI compared with younger women To determine if microvascular function is abnormal in young women undergoing percutaneous coronary revascularization with an acute MI compared to older women and men 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

Acute Coronary Syndrome, Women

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Gender comparison

Intervention Type

Procedure

Intervention Name(s)

IVUS

Intervention Description

Intravascular ultrasound with virtual histology

Primary Outcome Measure Information:

Title

Plaque Virtual Histology

Time Frame

Performed during PCI

Secondary Outcome Measure Information:

Title

Endothelial Progenitor Cells

Time Frame

Collected immediately pre PCI

Title

Microvascular function in the noninfarct related vessel

Time Frame

Assessed immediately post PCI

Title

Virtual Histology in noninfarct related vessel

Time Frame

Assessed immediately post PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patricia M. Best, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

http://clinicaltrials.mayo.edu

Description

Mayo Clinic Clinical Trials

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

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