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 measure
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 (if study stopped)
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, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Switzerland
Funder name
Schweizerische Herzstiftung
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Switzerland
Funder name
Pfizer
Alternative name(s)
Pfizer Inc., Pfizer Consumer Healthcare
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Roche
Alternative name(s)
F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25240454