Contact information
Type
Scientific
Primary contact
Dr Shamir Mehta
ORCID ID
Contact details
Hamilton Health Sciences
General Division
237 Barton Street
McMaster Clinic
Room 508
Hamilton
Ontario
L8L 2X2
Canada
Type
Public
Additional contact
Ms Brandi Meeks
ORCID ID
Contact details
Population Health Research Institute (PHRI)
McMaster University/Hamilton Health Sciences
237 Barton St E
Hamilton
ON L8L 2X2
Canada
+1 (0)905 527 4322 ext. 44818
brandi@cardio.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00552513
Protocol/serial number
MCT-79654
Study information
Scientific title
An International randomised trial of early versus delayed invasive strategies in patients with non-ST segment elevation acute coronary syndromes
Acronym
TIMACS
Study hypothesis
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
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
Study design
Therapeutic management strategy and procedures intervention type randomised parallel two-armed multicentre multi-national trial with accessor blinding
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
15/06/2005
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4000
Participant 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
Recruitment start date
15/06/2005
Recruitment end date
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
Trial participating centre
Hamilton Health Sciences
Hamilton, Ontario
L8L 2X2
Canada
Sponsor information
Organisation
Population Health Research Institute (PHRI) (Canada)
Sponsor details
McMaster University/Hamilton Health Sciences
237 Barton St East
Hamilton
Ontario
L8L 2X2
Canada
+1 (0)905 527 4322 ext. 44555
crackbe@phri.ca
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
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
See https://clinicaltrials.gov/ct2/show/results/NCT00552513
Publication summary