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

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

Sponsors

Lead Sponsor: The Young Investigator Group of Cardiovascular Research

Source The Young Investigator Group of Cardiovascular Research
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.

Overall Status Not yet recruiting
Start Date 2021-07-01
Completion Date 2022-12-01
Primary Completion Date 2022-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Angiographic results immediately after procedure
Angiographic results immediately after procedure
Angiographic results immediately after procedure
In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE) 10 days
Short term Major adverse cerebrovascular and cardiovascular events (MACCE) 6 months
Secondary Outcome
Measure Time Frame
Safety outcomes 10 days
In-Hospital Heart failure status 10 days
Short term Hospitalization due to heart failure 6 months
Enrollment 124
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Manual Thrombus Aspiration

Description: Manual thrombus aspiration using one of the FDA approved aspirators will be done.

Arm Group Label: Manual Thrombus Aspiration

Other Name: Thrombus Aspiration

Intervention Type: Procedure

Intervention Name: Standard PCI

Description: Standard PCI according to the most recent guidelines

Arm Group Label: Standard PCI

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Mahmoud H Abdelnabi, MD

Phone: +201007573530

Email: [email protected]

Location
Facility: Contact: Investigator:
Andalusia Hospitals | Alexandria, 21521, Egypt Haitham Badran, MD [email protected] Abdallah Almaghraby, MSc Sub-Investigator
International Cardiac Center (ICC) | Alexandria, 21524, Egypt Ahmed El Amrawy, MD +201006222922 [email protected] Ahmed M El Amrawy, MD Principal Investigator Ahmed Naguib, MSc Sub-Investigator
Ain Shams University Hospitals | Cairo, Egypt Haitham Badran
National Heart Institute | Giza, Egypt Yasser Sadek, MD
Location Countries

Egypt

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Manual Thrombus Aspiration

Type: Experimental

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

Label: Standard PCI

Type: Active Comparator

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)

Acronym TSUNAMI
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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