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Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role STEMI patients with heavy thrombus burden (TB).
The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role in STEMI patients with heavy thrombus burden (TB).
The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Thrombus Aspiration | Experimental | Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5) |
|
| Standard PCI | Active Comparator | Conventional PCI according to the most recent guidelines in STEMI patients with no heavy thrombus burden (TIMI 0-1 or TB classification 4-5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Thrombus Aspiration | Procedure | Manual thrombus aspiration using one of the FDA approved aspirators will be done. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic results | Successful revascularization assessed by TIMI flow | immediately after procedure |
| Angiographic results | Successful revascularization assessed by myocardial blush. | immediately after procedure |
| Angiographic results | Successful revascularization assessed by ST-segment resolution. | immediately after procedure |
| In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE) | Incidence of any major adverse cerebrovascular and cardiovascular events which includes: death (either all-cause or cardiac), nonfatal myocardial infarction, stroke and revascularization (with optional additional specification of target vessel or lesion, i.e., if the revascularization occurred at the site of a previously identified diseased coronary vessel or atherosclerotic lesion, respectively) | 10 days |
| Short term Major adverse cerebrovascular and cardiovascular events (MACCE) | Incidence of any major adverse cerebrovascular and cardiovascular events which includes: death (either all-cause or cardiac), nonfatal myocardial infarction, stroke and revascularization (with optional additional specification of target vessel or lesion, i.e., if the revascularization occurred at the site of a previously identified diseased coronary vessel or atherosclerotic lesion, respectively) in the period of 6 months after randomization. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any bleeding event (Safety outcomes) | Incidence of any bleeding event that may be encountered during the hospital stay after randomization. (Major or Minor) | 10 days |
| In-Hospital Heart failure status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haitham Badran, MD | Ain Shams University, Egypt | Study Chair |
| Mahmoud H Abdelnabi, MD | University of Alexandria - Egypt | Principal Investigator |
| Ahmed M El Amrawy, MD | University of Alexandria - Egypt | Study Director |
| Yasser Sadek, MD | National Heart Institute, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andalusia Hospitals | Alexandria | 21521 | Egypt | |||
| International Cardiac Center (ICC) |
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| Standard PCI | Procedure | Standard PCI according to the most recent guidelines |
|
Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.
| 10 days |
| Short term Hospitalization due to heart failure | Incidence of any event of heart failure that may be encountered during any other re-admission due to a "heart failure" diagnosis up to 6 months after randomization. | 6 months |
| Alexandria |
| 21524 |
| Egypt |
| Ain Shams University Hospitals | Cairo | Egypt |
| National Heart Institute | Giza | Egypt |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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