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

NCT ID: NCT04912570

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Percutaneous Coronary Intervention ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual Thrombus Aspiration

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

Group Type EXPERIMENTAL

Manual Thrombus Aspiration

Intervention Type PROCEDURE

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

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)

Group Type ACTIVE_COMPARATOR

Standard PCI

Intervention Type PROCEDURE

Standard PCI according to the most recent guidelines

Interventions

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Manual Thrombus Aspiration

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

Intervention Type PROCEDURE

Standard PCI

Standard PCI according to the most recent guidelines

Intervention Type PROCEDURE

Other Intervention Names

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Thrombus Aspiration

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Young Investigator Group of Cardiovascular Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haitham Badran, MD

Role: STUDY_CHAIR

Ain Shams University - Egypt

Mahmoud H Abdelnabi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria - Egypt

Ahmed M El Amrawy, MD

Role: STUDY_DIRECTOR

University of Alexandria - Egypt

Yasser Sadek, MD

Role: STUDY_DIRECTOR

National Heart Institute, Egypt

Locations

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Andalusia Hospitals

Alexandria, , Egypt

Site Status

International Cardiac Center (ICC)

Alexandria, , Egypt

Site Status

Ain Shams University Hospitals

Cairo, , Egypt

Site Status

National Heart Institute

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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YIG0502101

Identifier Type: -

Identifier Source: org_study_id

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