NCT02510703

Brief Summary

Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients. The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 22, 2022

Status Verified

August 1, 2015

Enrollment Period

4.8 years

First QC Date

July 27, 2015

Last Update Submit

March 8, 2022

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Comparison of quantitative variables coronary endothelial function in PET according to the presence or absence of type 2 diabetes in patients investigated with the waning of a first heart attack

    baseline

Study Arms (2)

Type 2 diabetes group

OTHER

Type 2 diabetes group

Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)

no diabetes

OTHER

no diabetes

Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)

Interventions

Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)OTHER
Type 2 diabetes groupno diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a first myocardial infarction, type 2 diabetic or non-diabetic treated by angioplasty in acute phase (TIMI 3)
  • Myocardial viability test before discharge
  • Age over 18 years
  • Informed Consent dated and signed by the patient
  • Written and spoken French
  • Beneficiary of social security insurance

You may not qualify if:

  • Hypertension\> 160/90 mmHg despite medical treatment
  • Lack of effective revascularization in acute phase of myocardial infarction (TIMI grade \<3)
  • Significant three-vessel coronary artery disease (\> 70% stenosis in the other two coronary arteries); occlusion of a coronary artery; schedule revascularization (percutaneous or surgical); left main coronary artery stenosis
  • Previous history of myocardial infarction
  • Mechanical complication (mitral regurgitation, ventricular septal rupture, left ventricular free wall rupture)
  • Heart failure
  • No myocardial viability test before discharge, for whatever reason
  • Type 1 diabetes
  • Pregnant and / or lactating
  • Age under 18 years or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Cardiologie

Caen, 14000, France

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 29, 2015

Study Start

March 1, 2011

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

March 22, 2022

Record last verified: 2015-08

Locations

FR(1)