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1.Research design: Intervention trial 1.1 Study domain: STEMI patients who will receive the fibrinolysis for reperfusion therapy 1.2 Target population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.3 Study population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital
Inclusion criteria:
Exclusion criteria:
1.4 Occurrence relation Y (Composite outcomes) = f (Treatment early vs. delay | confounders)
1.5 Setting: The study will be conducted in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.6 Determinant (x): Time to percutaneous coronary intervention (early vs. delayed).
1.7 Events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early ( < 24hr) | Active Comparator | Early percutaneous coronary intervention means performed coronary intervention between 3-24 hours after successful fibrinolytic therapy. |
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| Delay ( > 24 hours) | Active Comparator | Delay percutaneous coronary intervention means received coronary intervention >24 hours to 2 weeks after successfully fibrinolytic therapy. |
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| Early | Active Comparator | We randomized the patients into two groups early (≤ 24 hours) and delay group (> 24 hours) All patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin. Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Other | All patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin. Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct. |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcomes(included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure. | Composite outcomes included of death, re-infarction, recurrent ischemia, re-hospitalized with ACS and worsening heart failure at 30 days for short- and 6 months for long-term outcomes. Death was defined as all cause of death (cardiac and non-cardiac cause). Recurrent MI 'Incident MI' is defined as the individual's first MI. Re-infarction The term of 're-infarction' is used for an acute MI that occurs within 28 days of an incident- or recurrent MI. Re-hospitalized with ACS was defined as re-admission after discharge from hospital with acute coronary syndrome composed with clinical chest pain, rising of cardiac enzymes and dynamic ST-segment change. Re-hospitalized with heart failure was defined as re-admission after discharge from hospital with clinical decompensated heart failure. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiang Mai University | Chiang Mai | Chiang Mai | 50200 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31275432 | Derived | Chotechuang Y, Phrommintikul A, Kuanprasert S, Muenpa R, Patumanond J, Chaichuen T, Sukonthasarn A. Cardiovascular outcomes of early versus delayed coronary intervention in low to intermediate-risk patients with STEMI in Thailand: a randomised trial. Heart Asia. 2019 Jun 12;11(2):e011201. doi: 10.1136/heartasia-2019-011201. eCollection 2019. |
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|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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