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

Coronary Artery Disease Clinical Trial

— TSUNAMI  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04912570
• Other study ID #: YIG0502101
• Status: Suspended
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: The Young Investigator Group of Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 124
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• ST Elevation Myocardial Infarction
• Thrombosis

Intervention

Procedure:
• Manual Thrombus Aspiration
Manual thrombus aspiration using one of the FDA approved aspirators will be done.
• Standard PCI
Standard PCI according to the most recent guidelines

Locations

Country	Name	City	State
Egypt	Andalusia Hospitals	Alexandria
Egypt	International Cardiac Center (ICC)	Alexandria
Egypt	Ain Shams University Hospitals	Cairo
Egypt	National Heart Institute	Giza

Sponsors (1)

Lead Sponsor	Collaborator
The Young Investigator Group of Cardiovascular Research

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic results	Successful revascularization assessed by TIMI flow	immediately after procedure
Primary	Angiographic results	Successful revascularization assessed by myocardial blush.	immediately after procedure
Primary	Angiographic results	Successful revascularization assessed by ST-segment resolution.	immediately after procedure
Primary	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
Primary	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	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
Secondary	In-Hospital Heart failure status	Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.	10 days
Secondary	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