Clinical trial NCT04912570: Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction
Official title: Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
ST Elevation Myocardial Infarction
Keywords: Coronary Artery Disease
Myocardial Infarction
Percutaneous Coronary Intervention
Lead sponsor: The Young Investigator Group of Cardiovascular Research
Sponsor class: NETWORK
First posted: 2021-06-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Angiographic results
timeFrame: immediately after procedure
measure: Angiographic results
timeFrame: immediately after procedure
measure: Angiographic results
timeFrame: immediately after procedure
measure: In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)
timeFrame: 10 days
measure: Short term Major adverse cerebrovascular and cardiovascular events (MACCE)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of any bleeding event (Safety outcomes)
timeFrame: 10 days
measure: In-Hospital Heart failure status
timeFrame: 10 days
measure: Short term Hospitalization due to heart failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Andalusia Hospitals
city: Alexandria
country: Egypt
facility: International Cardiac Center (ICC)
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
city: Giza
country: Egypt
facility: National Heart Institute
Study officials:
affiliation: Ain Shams University - Egypt
name: Haitham Badran, MD
role: STUDY_CHAIR
affiliation: University of Alexandria - Egypt
name: Mahmoud H Abdelnabi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alexandria - Egypt
name: Ahmed M El Amrawy, MD
role: STUDY_DIRECTOR
affiliation: National Heart Institute, Egypt
name: Yasser Sadek, MD
role: STUDY_DIRECTOR
References: