Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial

Conditions
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Coronary Artery Disease, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction

Intervention / Treatment
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* Procedure: Manual Thrombus Aspiration
* Procedure: Standard PCI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Thrombus Aspiration<br>Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5) | Procedure: Manual Thrombus Aspiration<br>* Manual thrombus aspiration using one of the FDA approved aspirators will be done.<br>* Other names: Thrombus Aspiration;|
| Active Comparator: Standard PCI<br>Conventional PCI according to the most recent guidelines in STEMI patients with no heavy thrombus burden (TIMI 0-1 or TB classification 4-5) | Procedure: Standard PCI<br>* Standard PCI according to the most recent guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention