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| Name | Class |
|---|---|
| Helwan University | OTHER |
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This study compares two treatment strategies in patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing a pharmaco-invasive approach after successful fibrinolysis. The study evaluates whether one-time complete revascularization, in which the culprit and significant non-culprit lesions are treated during the same percutaneous coronary intervention (PCI) session, is better than a staged strategy, in which non-culprit lesions are treated in a separate percutaneous coronary intervention (PCI) procedure within 1 month.
The hypothesis is that one-time complete revascularization may reduce hospitalization time, cost, and recurrent ischemic symptoms without increasing short-term complications.
Participants are adults with acute ST-elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) who had successful fibrinolysis followed by coronary angiography and percutaneous coronary intervention (PCI). Outcomes include total hospitalization time, total expenses, contrast-induced nephropathy (CIN) within 72 hours, and major adverse cardiovascular events (MACE) during 3 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-Time Complete Revascularization | Experimental | Participants underwent one-time complete revascularization during the index percutaneous coronary intervention after successful fibrinolysis. The culprit coronary artery and all significant non-culprit lesions were treated during the same procedure. |
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| Staged Percutaneous Coronary Intervention | Active Comparator | Participants underwent culprit-only percutaneous coronary intervention during the index procedure after successful fibrinolysis. Significant non-culprit lesions were treated in a separate staged percutaneous coronary intervention session within 1 month after discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-Time Complete Revascularization | Procedure | Revascularization strategy in which the culprit coronary artery and all significant non-culprit lesions are treated during the index percutaneous coronary intervention session after successful fibrinolysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Total hospitalization time | Total duration of hospitalization in days. For participants assigned to staged revascularization, the duration of the staged admission was added to the index admission to calculate the total hospitalization time. | up to 1 month post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total expenses | Total treatment-related expenses in Egyptian pounds for the index admission and, when applicable, the staged admission. | up to 1 month post operatively |
| Contrast-induced nephropathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helwan University Hospital | Cairo | Cairo Governorate | 11795 | Egypt |
De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers. Shared data may include baseline demographic and clinical characteristics, procedural data, laboratory results, echocardiographic findings, hospitalization data, and follow-up outcome data used in the published analyses. All shared data will be fully de-identified to protect participant privacy.
Data will be available beginning 6 months after publication of the study results and will remain available for 5 years.
Access will be provided to qualified researchers for scientifically sound research purposes after submission and approval of a methodologically appropriate proposal. Requests should include the study objectives, analysis plan, and intended use of the data. Data sharing will require approval by the principal investigator and institution, and may require a signed data use agreement.
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Participants were randomized in a parallel two-arm design to undergo either one-time complete revascularization during the index percutaneous coronary intervention or culprit-only percutaneous coronary intervention followed by staged non-culprit percutaneous coronary intervention within 1 month after discharge.
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This was an open-label study. Participants, care providers, and investigators were aware of treatment assignment because the timing and extent of revascularization differed by protocol. No formal masking of outcome assessment was specified.
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| Staged Percutaneous Coronary Intervention | Procedure | Revascularization strategy in which only the culprit coronary artery is treated during the index percutaneous coronary intervention session after successful fibrinolysis, with treatment of significant non-culprit lesions deferred to a separate staged percutaneous coronary intervention within 1 month after discharge. |
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Increase in serum creatinine by at least 0.5 milligrams per deciliter or at least 25 percent from baseline within 72 hours after percutaneous coronary intervention.
| Within 72 hours after percutaneous coronary intervention |
| Angina-related hospitalization | Hospital admission due to recurrent anginal symptoms during follow-up. | Within 3 months after index percutaneous coronary intervention |
| Left ventricular ejection fraction | Left ventricular systolic function assessed by transthoracic echocardiography using the modified Simpson method. | Baseline and 3 months after index percutaneous coronary intervention |
| Wall motion score index | Regional left ventricular wall motion score index assessed by transthoracic echocardiography. | Baseline and 3 months after index percutaneous coronary intervention |
| Serum creatinine | Serum creatinine concentration measured to assess renal function. | Baseline, 72 hours after percutaneous coronary intervention, and 3 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |