Trial of Invasive versus Medical therapy of Early coronary artery disease in Diabetes Mellitus
| ISRCTN | ISRCTN87953632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87953632 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Basel - Department of Cardiology (Switzerland) |
| Funders | Swiss National Science Foundation, Schweizerische Herzstiftung, Pfizer, Roche, Takeda , Haider |
- Submission date
- 25/07/2005
- Registration date
- 14/09/2005
- Last edited
- 24/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Matthias Pfisterer
Scientific
Scientific
Cardiology Department
University Hospital
Basel
CH-4031
Switzerland
| pfisterer@email.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Trial of Invasive versus Medical therapy of Early coronary artery disease in Diabetes Mellitus |
| Study acronym | TIME-DM |
| Study objectives | Early detection and treatment of silent coronary artery disease (CAD) in diabetic patients may be beneficial. |
| Ethics approval(s) | Received 28/11/2003 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cardiac death, myocardial infarction, onset of angina, or hospitalization (for acute coronary syndrom or symptomatic need for revascularization). |
| Key secondary outcome measure(s) |
Angina class, quality of life, impact of medical therapy. |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key 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). |
| Key exclusion criteria | Concomitant disease with prognosis less than 3 years survival. Older than 75 years. End stage renal disease or dialysis. |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital
Basel
CH-4031
Switzerland
CH-4031
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2014 | Yes | No |
