Myocardial Perfusion Study to Detect Coronary Microvascul... | NCT01749683

Studies
Myocardial Perfusion Study to Detect Coronary Microvascular Abnormality in Diabetic Patients With Nonfatal Myocardial Infarction

NCT01749683

Sponsor

State University of New York - Upstate Medical University

Status

Completed

Last Update Posted

Oct 20, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Dec 13, 2012

First Posted Date

Dec 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2021

Last Update Posted Date

Oct 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Upstate Medical University		Syracuse	New York	13210	United States

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided