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

Not Applicable

Suspended

• Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention
• Interventions: Procedure: Standard PCI; Procedure: Manual Thrombus Aspiration

• Registration Number: NCT04912570
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-03
• Study Start: 2022-07-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-14
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard PCI	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)
Manual Thrombus Aspiration	Manual Thrombus Aspiration	Manual Thrombus aspiration in STEMI patients with Heavy thrombus burden (TIMI 0-1 or TB classification 4-5)

Primary Outcome Measures

Name	Time	Method
Angiographic results	immediately after procedure	Successful revascularization assessed by ST-segment resolution.
In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)	10 days	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)	6 months	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

Name	Time	Method
Short term Hospitalization due to heart failure	6 months	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.
Incidence of any bleeding event (Safety outcomes)	10 days	Incidence of any bleeding event that may be encountered during the hospital stay after randomization. (Major or Minor)
In-Hospital Heart failure status	10 days	Incidence of any event of heart failure that may be encountered during the hospital stay after randomization.

Trial Locations

Locations (4)

Andalusia Hospitals; 🇪🇬 Alexandria, Egypt

National Heart Institute; 🇪🇬 Giza, Egypt

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt

International Cardiac Center (ICC); 🇪🇬 Alexandria, Egypt