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

Primary Purpose

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

Status
Suspended
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Manual Thrombus Aspiration
Standard PCI
Sponsored by
The Young Investigator Group of Cardiovascular Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Andalusia Hospitals
  • International Cardiac Center (ICC)
  • Ain Shams University Hospitals
  • National Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual Thrombus Aspiration

Standard PCI

Arm Description

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

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

Outcomes

Primary Outcome Measures

Angiographic results
Successful revascularization assessed by TIMI flow
Angiographic results
Successful revascularization assessed by myocardial blush.
Angiographic results
Successful revascularization assessed by ST-segment resolution.
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)
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.

Secondary Outcome Measures

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)
In-Hospital Heart failure status
Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.
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.

Full Information

First Posted
May 19, 2021
Last Updated
July 11, 2023
Sponsor
The Young Investigator Group of Cardiovascular Research
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1. Study Identification

Unique Protocol Identification Number
NCT04912570
Brief Title
Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction
Acronym
TSUNAMI
Official Title
Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
No catheters
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Young Investigator Group of Cardiovascular Research

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Percutaneous Coronary Intervention, ST Elevation Myocardial Infarction
Keywords
Coronary Artery Disease, Myocardial Infarction, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Thrombus Aspiration
Arm Type
Experimental
Arm Description
Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5)
Arm Title
Standard PCI
Arm Type
Active Comparator
Arm 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)
Intervention Type
Procedure
Intervention Name(s)
Manual Thrombus Aspiration
Other Intervention Name(s)
Thrombus Aspiration
Intervention Description
Manual thrombus aspiration using one of the FDA approved aspirators will be done.
Intervention Type
Procedure
Intervention Name(s)
Standard PCI
Intervention Description
Standard PCI according to the most recent guidelines
Primary Outcome Measure Information:
Title
Angiographic results
Description
Successful revascularization assessed by TIMI flow
Time Frame
immediately after procedure
Title
Angiographic results
Description
Successful revascularization assessed by myocardial blush.
Time Frame
immediately after procedure
Title
Angiographic results
Description
Successful revascularization assessed by ST-segment resolution.
Time Frame
immediately after procedure
Title
In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)
Description
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)
Time Frame
10 days
Title
Short term Major adverse cerebrovascular and cardiovascular events (MACCE)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence of any bleeding event (Safety outcomes)
Description
Incidence of any bleeding event that may be encountered during the hospital stay after randomization. (Major or Minor)
Time Frame
10 days
Title
In-Hospital Heart failure status
Description
Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.
Time Frame
10 days
Title
Short term Hospitalization due to heart failure
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitham Badran, MD
Organizational Affiliation
Ain Shams University - Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmoud H Abdelnabi, MD
Organizational Affiliation
University of Alexandria - Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed M El Amrawy, MD
Organizational Affiliation
University of Alexandria - Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yasser Sadek, MD
Organizational Affiliation
National Heart Institute, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Andalusia Hospitals
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
Facility Name
International Cardiac Center (ICC)
City
Alexandria
ZIP/Postal Code
21524
Country
Egypt
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt
Facility Name
National Heart Institute
City
Giza
Country
Egypt

12. IPD Sharing Statement

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

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