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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN20993046 | Registry Identifier | International Standard Randomised Controlled Trial Number |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Hamilton Health Sciences Corporation | OTHER |
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The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Coronary Intervention | Other | Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation). |
|
| Delayed Coronary Intervention | Other | Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Coronary Intervention | Procedure | Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (and within 24 hours of randomisation). |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Death, Myocardial (re-) Infarction, or Stroke | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia | 180 days | |
| Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days | 180 days |
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Inclusion Criteria:
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 ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain)
Able to randomise within 24 hours of the onset of the most recent episode of symptoms
At least two of the three following additional criteria:
Written informed consent dated and signed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamir Mehta, MD, MSc | Population Health Research Institute, Hamilton Health Sciences, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16338245 | Background | MICHELANGELO OASIS 5 Steering Committee; Mehta SR, Yusuf S, Granger CB, Wallentin L, Peters RJ, Bassand JP, Budaj A, Joyner C, Chrolavicius S, Fox KA. Design and rationale of the MICHELANGELO Organization to Assess Strategies in Acute Ischemic Syndromes (OASIS)-5 trial program evaluating fondaparinux, a synthetic factor Xa inhibitor, in patients with non-ST-segment elevation acute coronary syndromes. Am Heart J. 2005 Dec;150(6):1107. doi: 10.1016/j.ahj.2005.09.025. | |
| 19458363 |
| Label | URL |
|---|---|
| Population Health Research Institute | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Early | Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation). |
| FG001 | Delayed | Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Early | Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation). |
| BG001 | Delayed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of Death, Myocardial (re-) Infarction, or Stroke | All patients were included in the final intention-to-treat analysis. Event rates in the two groups were estimated with the use of the Kaplan-Meier method. The hazard ratio and two-sided 95% confidence intervals were calculated with the use of a Cox proportional-hazards model. | Posted | Number | participants | 180 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early | Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TIMACS Project Office | Population Health Research Institute | 19055244322 | timacs@phri.ca |
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| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Delayed Coronary Intervention | Procedure | Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation. |
|
| Stroke at 30 Days and 180 Days | 180 days |
| Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180 | 180 days |
| In-hospital Major Bleeding | Hospital discharge |
| Result |
| Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, Afzal R, Chrolavicius S, Jolly SS, Widimsky P, Avezum A, Rupprecht HJ, Zhu J, Col J, Natarajan MK, Horsman C, Fox KA, Yusuf S; TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2165-75. doi: 10.1056/NEJMoa0807986. |
Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
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|
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| Secondary | First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia | Posted | Number | participants | 180 days |
|
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| Secondary | Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days | Posted | Number | Eparticipants | 180 days |
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| Secondary | Stroke at 30 Days and 180 Days | Not Posted | 180 days | Participants |
| Secondary | Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180 | Not Posted | 180 days | Participants |
| Secondary | In-hospital Major Bleeding | Not Posted | Hospital discharge | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Delayed | Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation. | 0 | 0 | 0 | 0 |
PHRI agreements may vary with individual investigators, but will not prohibit any investigator from publishing. PHRI supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |