Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction (GEMyCE 1)

October 19, 2021 updated by: State University of New York - Upstate Medical University
The goal of this study is to use MCE (myocardial contrast/perfusion echocardiography) to study and compare short/long term change of myocardial perfusion abnormality and cardiac outcome in diabetic patients after nonfatal MI (heart attack), who are treated with different glucose control agents.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG

Description

Inclusion Criteria:

  • Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG

Exclusion Criteria:

  • Patients are excluded if they are older than 70 year old, require mechanical ventilation, are receiving intravenous pressors or hemodynamic support, or if the motion of segments associated with infarct-related artery can not be accurately determined.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perfusion abnormalities in nondiabetic and diabetic patients
Time Frame: short term (3 month) and long term (12 month).
short term (3 month) and long term (12 month).

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of different glycemic control strategies on the reduction of coronary injury in diabetic and non-diabetic subjects
Time Frame: short term (3 month) and long term (12 month)
short term (3 month) and long term (12 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMyCE1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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