TiMing of Intervention in patients with Acute Coronary Syndromes
ISRCTN | ISRCTN20993046 |
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DOI | https://doi.org/10.1186/ISRCTN20993046 |
ClinicalTrials.gov number | NCT00552513 |
Secondary identifying numbers | MCT-79654 |
- Submission date
- 27/11/2006
- Registration date
- 27/11/2006
- Last edited
- 10/04/2019
- 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
Dr Shamir Mehta
Scientific
Scientific
Hamilton Health Sciences
General Division
237 Barton Street
McMaster Clinic
Room 508
Hamilton, Ontario
L8L 2X2
Canada
Ms Brandi Meeks
Public
Public
Population Health Research Institute (PHRI)
McMaster University/Hamilton Health Sciences
237 Barton St E
Hamilton
ON L8L 2X2
Canada
Phone | +1 (0)905 527 4322 ext. 44818 |
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brandi@cardio.on.ca |
Study information
Study design | Therapeutic management strategy and procedures intervention type randomised parallel two-armed multicentre multi-national trial with accessor blinding |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | An International randomised trial of early versus delayed invasive strategies in patients with non-ST segment elevation acute coronary syndromes |
Study acronym | TIMACS |
Study objectives | 1. In patients with acute coronary syndromes (ACS), a strategy of routine early coronary angiography (less than 24 hours after randomisation) and intervention is superior to a strategy of delayed coronary angiography (more than 36 hours after randomisation) and intervention in preventing major cardiovascular events 2. In patients with ACS, a delayed invasive strategy will result in lower rates of major bleeding versus a strategy of early angiography and revascularisation 3. A strategy of early coronary angiography and revascularisation will be more cost effective than a strategy of delayed coronary angiography and revascularisation |
Ethics approval(s) | 1. Research Ethics Board of the Hamilton Health Sciences/McMaster Health Sciences, Hamilton, Ontario, Canada, 26/05/2005 2. Comité de Ética em Pesquisa, Santa Casa de Belo Horizonte, Belo Horizonte, Brazil, 29/05/2006 3. Comité d'Ethique Médicale, Centre Hospitauer Regional De Huy, De Huy, Belgium, 12/10/2005 4. Ethics Committee of the Middle Slovak Institute of Cardiovascular Diseases, Banska Bistrica, Slovakia, 26/10/2006 5. University Clinical Emergency Hospital Mures Clinic of Cardiology, Targu Mures, Romania, 01/11/2006 |
Health condition(s) or problem(s) studied | Acute coronary syndromes (unstable angina and non-ST segment elevation myocardial infarction) |
Intervention | Early intervention: Coronary angiography and intervention as soon as possible (within 24 hours of randomisation). Delayed intervention: Coronary angiography and intervention any time after 36 hours after randomisation. |
Intervention type | Procedure/Surgery |
Primary outcome measure | The first occurrence of the composite death/myocardial (re-)infarction/stroke up to day 180. |
Secondary outcome measures | 1. The composite of death, myocardial (re-)infarction, stroke, refractory ischaemia or repeat revascularisation at 180 days 2. The first occurrence of any component of the composite of death myocardial infarction and refractory ischaemia until day 14, 30, 90 and at six months (day 180) 3. Stroke at 30 days and 180 days 4. Need for mechanical or pharmacological coronary revascularisation (i.e., percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG], thrombolysis) at days 30, 90 and 180 days |
Overall study start date | 15/06/2005 |
Completion date | 01/05/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 4000 |
Key inclusion criteria | 1. Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome (unstable angina or MI without persistent ST elevation), i.e. clinical history consistent with new onset, or a worsening pattern, of characteristic ischaemic chest pain or ischaemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain) 2. Able to randomise within 24 hours of the onset of the most recent episode of symptoms 3. At least two of the three following additional criteria: 3.1. Age more than or equal to 60 years, either sex 3.2. Troponin T or I or creatine kinase - myocardial bands (CK-MB) above the upper limit of normal for the local institution 3.3. Electrocardiogram (ECG) changes compatible with ischaemia (i.e., ST depression at least 1 mm in two contiguous leads or T wave inversion mroe than 3 mm or any dynamic ST shift or transient ST elevation) 4. Written informed consent dated and signed |
Key exclusion criteria | 1. Age less than 21 years 2. Not a suitable candidate for revascularisation 3. Co-morbid condition with life expectancy less than six months |
Date of first enrolment | 15/06/2005 |
Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- Argentina
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Czech Republic
- France
- Germany
- Greece
- India
- Poland
- Romania
- Slovakia
- Slovenia
- Switzerland
- United States of America
Study participating centre
Hamilton Health Sciences
Hamilton, Ontario
L8L 2X2
Canada
L8L 2X2
Canada
Sponsor information
Population Health Research Institute (PHRI) (Canada)
Research organisation
Research organisation
McMaster University/Hamilton Health Sciences
237 Barton St East
Hamilton, Ontario
L8L 2X2
Canada
Phone | +1 (0)905 527 4322 ext. 44555 |
---|---|
crackbe@phri.ca | |
Website | http://www.phri.ca |
https://ror.org/03kwaeq96 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
Intention to publish date | |
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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? |
---|---|---|---|---|---|
Basic results | No | No | |||
Results article | results | 21/05/2009 | 10/04/2019 | Yes | No |
Editorial Notes
10/04/2019: Publication reference added.