Condition category
Circulatory System
Date applied
25/07/2005
Date assigned
14/09/2005
Last edited
24/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Matthias Pfisterer

ORCID ID

Contact details

Cardiology Department
University Hospital
Basel
CH-4031
Switzerland
-
pfisterer@email.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Trial of Invasive versus Medical therapy of Early coronary artery disease in Diabetes Mellitus

Acronym

TIME-DM

Study hypothesis

Early detection and treatment of silent coronary artery disease (CAD) in diabetic patients may be beneficial.

Ethics approval

Received 28/11/2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Early asymptomatic coronary artery disease in diabetic patients

Intervention

A randomized prospective study of medical therapy versus invasive evaluation of CAD and subsequent revascularization

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cardiac death, myocardial infarction, onset of angina, or hospitalization (for acute coronary syndrom or symptomatic need for revascularization).
Myocardial perfusion changes over time: Evolution of ischemic burden and overall abnormality.

Secondary outcome measures

Angina class, quality of life, impact of medical therapy.
Myocardial perfusion single photon emission computed tomography (SPECT) variables. Left ventricular ejection fraction, volumes.

Overall trial start date

01/05/2004

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with diabetes type 2, asymptomatic with respect to angina, no prior coronary artery disease; high risk profile for coronary artery disease (pathologic electrocardiogram [ECG], peripheral vascular disease, microalbuminuria, cardiac autonomic neuropathy, retinopathy, or more than one addititional risk factor for CAD).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 400

Participant exclusion criteria

Concomitant disease with prognosis less than 3 years survival. Older than 75 years. End stage renal disease or dialysis.

Recruitment start date

01/05/2004

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital
Basel
CH-4031
Switzerland

Sponsor information

Organisation

University Hospital Basel - Department of Cardiology (Switzerland)

Sponsor details

Petersgraben 4
Basel
CH-4031
Switzerland
-
pfisterer@email.ch

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Swiss National Science Foundation

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Funder name

Schweizerische Herzstiftung

Alternative name(s)

Swiss Heart Foundation, Fondation Suisse de Cardiologie, Fondazione Svizzera di Cardiologia

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Switzerland

Funder name

Pfizer

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Roche

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Funder name

Takeda

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Haider

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25240454

Publication citations

Additional files

Editorial Notes