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

Last updated: July 11, 2023
Sponsor: The Young Investigator Group of Cardiovascular Research
Overall Status: Suspended

Phase

N/A

Condition

Myocardial Ischemia

Chest Pain

Blood Clots

Treatment

Manual Thrombus Aspiration

Standard PCI

Clinical Study ID

NCT04912570
YIG0502101
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 orsuspected contraindications to the study drugs.
  • Symptomatic hypotension and/or an SBP < 100 mmHg at the time of randomization.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Manual Thrombus Aspiration
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Andalusia Hospitals

    Alexandria, 21521
    Egypt

    Site Not Available

  • International Cardiac Center (ICC)

    Alexandria, 21524
    Egypt

    Site Not Available

  • Ain Shams University Hospitals

    Cairo,
    Egypt

    Site Not Available

  • National Heart Institute

    Giza,
    Egypt

    Site Not Available

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