Myocardial InfarctionGEMyCE 1NCT01749683
Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction
An observational study of Myocardial Infarction, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Myocardial Infarction
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG
Who may be able to join
- Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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.
- Conditions
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion abnormalities in nondiabetic and diabetic patients
Measured: short term (3 month) and long term (12 month).
Secondary outcomes (1)
The effect of different glycemic control strategies on the reduction of coronary injury in diabetic and non-diabetic subjects
Measured: short term (3 month) and long term (12 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749683
- Sponsor's protocol ID
- GEMyCE1
- Acronym
- GEMyCE 1
- Status last verified
- Apr 2016
- First submitted
- 12 Dec 2012
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01749683
- Acronym / sponsor ID
- GEMyCE 1 / GEMyCE1
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG
Key inclusion criteria (1 listed)
- Diabetic and nondiabetic patients will be initially recruited and studied after acute nonfatal MI and revascularization with either PCI or CABG
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfusion abnormalities in nondiabetic and diabetic patients
Time frame: short term (3 month) and long term (12 month).
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion abnormalities in nondiabetic and diabetic patients (time frame: short term (3 month) and long term (12 month).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.