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

NCT04912570 | Suspended DMC

• 1 other identifier: YIG0502101
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Coronary Artery Disease; Myocardial Infarction; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (5)

• Angiographic results

  Successful revascularization assessed by TIMI flow

  immediately after procedure

• Angiographic results

  Successful revascularization assessed by myocardial blush.

  immediately after procedure

• Angiographic results

  Successful revascularization assessed by ST-segment resolution.

  immediately after procedure

• 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

• 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 Outcomes (3)

• Incidence of any bleeding event (Safety outcomes)

  10 days

• In-Hospital Heart failure status

  10 days

• Short term Hospitalization due to heart failure

  6 months

Study Arms (2)

Manual Thrombus Aspiration

EXPERIMENTAL

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

Procedure: Manual Thrombus Aspiration

Standard PCI

ACTIVE COMPARATOR

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

Procedure: Standard PCI

Interventions

Manual Thrombus Aspiration PROCEDURE

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

Also known as: Thrombus Aspiration

Manual Thrombus Aspiration

Standard PCI PROCEDURE

Standard PCI according to the most recent guidelines

Standard PCI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Young Investigator Group of Cardiovascular Research: lead

Study Sites (4)

Andalusia Hospitals

Alexandria, 21521, Egypt

Location

International Cardiac Center (ICC)

Alexandria, 21524, Egypt

Location

Ain Shams University Hospitals

Cairo, Egypt

Location

National Heart Institute

Giza, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Haitham Badran, MD

  Ain Shams University, Egypt

  STUDY CHAIR

• Mahmoud H Abdelnabi, MD

  University of Alexandria - Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed M El Amrawy, MD

  University of Alexandria - Egypt

  STUDY DIRECTOR

• Yasser Sadek, MD

  National Heart Institute, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 3, 2021
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

EG (4)