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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Manual thrombus aspiration using one of the FDA approved aspirators will be done.
Standard PCI according to the most recent guidelines
Andalusia Hospitals
Alexandria, Egypt
International Cardiac Center (ICC)
Alexandria, Egypt
Ain Shams University Hospitals
Cairo, Egypt
National Heart Institute
Giza, Egypt
Angiographic results
Successful revascularization assessed by TIMI flow
Time frame: immediately after procedure
Angiographic results
Successful revascularization assessed by myocardial blush.
Time frame: immediately after procedure
Angiographic results
Successful revascularization assessed by ST-segment resolution.
Time frame: 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)
Time frame: 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.
Time frame: 6 months
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)
Time frame: 10 days
In-Hospital Heart failure status
Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.
Time frame: 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.
Time frame: 6 months
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