NCT01839071

Brief Summary

The purpose of this study is to investigate if patients with coronary heart disease have higher risk to develop diabetes mellitus among the following two years. The examination of biomarkers taken from blood and fat issue shall provide which factors could be responsible for development of diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 25, 2014

Status Verified

November 1, 2013

Enrollment Period

3.9 years

First QC Date

March 21, 2013

Last Update Submit

June 24, 2014

Conditions

Coronary Artery Disease(CAD)

Outcome Measures

Primary Outcomes (1)

  • Fat tissue biopsy

    Patients with Coronary artery disease(CAD) undergo a subcutane fat tissue biopsy to identify inflammation and diabetes biomarker, such as TNF, Adiponectin and Clock-Gene. This is done baseline, after 1 year and after 2 years. Comparison of the current measurements among the measurements of the following 2 years shall give evidence about the reasons and conditions of diabetes development.

    2 years

Secondary Outcomes (1)

  • Blood collection

    2 years

Study Arms (1)

biopsy of fat tissue

OTHER
Procedure: biopsy

Interventions

biopsyPROCEDURE
biopsy of fat tissue

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients with MI
  • signed informed consent
  • older than 18 years
  • ability to give informed consent

You may not qualify if:

  • absence of legal competence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, North Rhine Westfalia, 52074, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2013

First Posted

April 24, 2013

Study Start

June 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 25, 2014

Record last verified: 2013-11

Locations

DE(1)