Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- The Young Investigator Group of Cardiovascular Research
- Enrollment
- 124
- Locations
- 4
- Primary Endpoint
- Angiographic results
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5
Exclusion Criteria
- •STEMI patients with low thrombus burden (TIMI 2-3 or TB 0-3)
- •History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
- •Symptomatic hypotension and/or an SBP \< 100 mmHg at the time of randomization.
Outcomes
Primary Outcomes
Angiographic results
Time Frame: immediately after procedure
Successful revascularization assessed by ST-segment resolution.
In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)
Time Frame: 10 days
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)
Short term Major adverse cerebrovascular and cardiovascular events (MACCE)
Time Frame: 6 months
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.
Secondary Outcomes
- Short term Hospitalization due to heart failure(6 months)
- Incidence of any bleeding event (Safety outcomes)(10 days)
- In-Hospital Heart failure status(10 days)