NCT01422057

Brief Summary

The purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 23, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

4 years

First QC Date

August 9, 2011

Last Update Submit

February 5, 2014

Conditions

Type-2 Diabetes MellitusIschemic Heart Disease

Keywords

diabetescoronary artery diseaseischemic heart diseaseautonomic functionheart rate turbulencedeceleration capacitysevere autonomic failure

Outcome Measures

Primary Outcomes (1)

  • Major cardiovascular event

    Combination of total mortality, non-fatal myocardial infarction and non-fatal stroke

    2 years

Secondary Outcomes (3)

  • Cardiovascular mortality

    2 years

  • sudden cardiac death

    2 years

  • Total mortality

    2 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with diagnose of ischemic heart disease and type-2 diabetes are included.

You may qualify if:

  • type-2 diabetes
  • coronary artery disease

You may not qualify if:

  • age \>80 years
  • acute coronary syndrome
  • life expectancy \<1 year
  • unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology

Tübingen, Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaDiabetes MellitusCoronary Artery DiseasePure Autonomic Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesPrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Central Study Contacts

Christine Zürn, MD

CONTACT

+49 7071 29 83153christine.zuern@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Axel Bauer

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 23, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

DE(1)