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

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

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.

Study Overview

• Status: Suspended
• Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention
• Intervention / Treatment: Procedure: Manual Thrombus Aspiration; Procedure: Standard PCI

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.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21524
    • International Cardiac Center (ICC)
  • Alexandria, Egypt, 21521
    • Andalusia Hospitals
  • Cairo, Egypt
    • Ain shams university hospitals
  • Giza, Egypt
    • National Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Thrombus Aspiration; Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5)	Procedure: Manual Thrombus Aspiration; Manual thrombus aspiration using one of the FDA approved aspirators will be done.; Other Names: Thrombus Aspiration
Active Comparator: Standard PCI; 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; Standard PCI according to the most recent guidelines

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: The Young Investigator Group of Cardiovascular Research
• Investigators: Study Chair: Haitham Badran, MD, Ain Shams University - Egypt; Principal Investigator: Mahmoud H Abdelnabi, MD, University of Alexandria - Egypt; Study Director: Ahmed M El Amrawy, MD, University of Alexandria - Egypt; Study Director: Yasser Sadek, MD, National Heart Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; ST Elevation Myocardial Infarction; Thrombosis
• Other Study ID Numbers: YIG0502101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No