NCT00685984

Brief Summary

Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

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

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 28, 2011

Status Verified

May 1, 2011

Enrollment Period

2.4 years

First QC Date

May 26, 2008

Last Update Submit

October 27, 2011

Conditions

Myocardial Ischemia

Keywords

Type 2 diabetessilent myocardial ischemiaendothelial function

Outcome Measures

Primary Outcomes (1)

  • Post-occlusive hyperaemia endothelium-dependent brachial artery dilation

    immediate

Secondary Outcomes (4)

  • noninvasive coronary microcirculation assessed with transthoracic ECHODOPPLER

    immediate

  • cardiac autonomic neuropathy

    immediate

  • cardiac transthoracic echography

    immediate

  • biologic markers of endothelial function

    immediate

Study Arms (3)

1

2

3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* type 2 diabetes * overweight free of diabetes * control

You may qualify if:

  • FOR TYPE 2 DIABETIC PATIENTS Asymptomatic:
  • with normal resting ECG
  • coronary primary prevention
  • other cardiovascular risk factors justifying screening for silent myocardial ischemia and coronary stenoses in case of silent myocardial ischemia.
  • FOR PATIENTS WITH OVERWEIGHT:
  • Asymptomatic with normal resting ECG
  • coronary primary prevention
  • Body mass index 25-40 kg/m²
  • Without diabetes.
  • CONTROLS Asymptomatic:
  • coronary primary prevention
  • Body mass index 18-25 kg/m²
  • Without diabetes
  • Without cardiovascular risk factors including dyslipidemia, hypertension, smoking habits, No treatment

You may not qualify if:

  • pregnancy
  • renal failure
  • acrosyndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition

Bondy, 93140, France

Location

Related Publications (3)

  • Cosson E, Pham I, Valensi P, Paries J, Attali JR, Nitenberg A. Impaired coronary endothelium-dependent vasodilation is associated with microalbuminuria in patients with type 2 diabetes and angiographically normal coronary arteries. Diabetes Care. 2006 Jan;29(1):107-12. doi: 10.2337/diacare.29.1.107.

    PMID: 16373905RESULT

  • Pham I, Nguyen MT, Valensi P, Rousseau H, Nitenberg A, Vicaut E, Cosson E. Noninvasive study of coronary microcirculation response to a cold pressor test. Eur J Clin Invest. 2015 Feb;45(2):135-43. doi: 10.1111/eci.12389. Epub 2015 Jan 7.

    PMID: 25490913DERIVED

  • Nguyen MT, Pham I, Valensi P, Rousseau H, Vicaut E, Laguillier-Morizot C, Nitenberg A, Cosson E. Flow-mediated-paradoxical vasoconstriction is independently associated with asymptomatic myocardial ischemia and coronary artery disease in type 2 diabetic patients. Cardiovasc Diabetol. 2014 Jan 15;13:20. doi: 10.1186/1475-2840-13-20.

    PMID: 24428877DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum

MeSH Terms

Conditions

Myocardial IschemiaDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Emmanuel COSSON, MD phD

    Hôpital Jean Verdier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2008

First Posted

May 29, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

October 28, 2011

Record last verified: 2011-05

Locations

FR(1)