Trial of Invasive versus Medical therapy of Early coronary artery disease in Diabetes Mellitus
| ISRCTN | ISRCTN87953632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87953632 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/05/2004 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | At least 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
Sponsor information
University Hospital Basel - Department of Cardiology (Switzerland)
University/education
University/education
Petersgraben 4
Basel
CH-4031
Switzerland
| pfisterer@email.ch | |
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Industry
Swiss National Science Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Schweizerischer Nationalfonds, Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerische Nationalfonds, SNF, SNSF, FNS
- Location
- Switzerland
Schweizerische Herzstiftung
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Swiss Heart Foundation, Fondation Suisse de Cardiologie, Fondazione Svizzera di Cardiologia, HerzstiftungCH
- Location
- Switzerland
Pfizer
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Roche
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
- Location
- Switzerland
Takeda
No information available
Haider
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2014 | Yes | No |
