Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction (TSUNAMI)

The Young Investigator Group of Cardiovascular Research

Status: Suspended

Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention

Treatments: Procedure: Standard PCI; Procedure: Manual Thrombus Aspiration

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04912570

YIG0502101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Manual Thrombus Aspiration

Experimental group

Description:

Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5)

Treatment:

Procedure: Manual Thrombus Aspiration

Standard PCI

Active Comparator group

Description:

Conventional PCI according to the most recent guidelines in STEMI patients with no heavy thrombus burden (TIMI 0-1 or TB classification 4-5)

Treatment:

Procedure: Standard PCI