Thrombus Aspiration in Patients With STEMI

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: ST-segment Elevation Myocardial Infarction

Treatments: Device: thrombus aspiration; Procedure: percutaneous coronary intervention (PCI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02606435

SEED

Details and patient eligibility

About

This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).

Full description

This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-80;
• Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;
• Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;
• Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;
• Informed consent.

Exclusion criteria

• Previous history of myocardiopathy, valvular heart disease or severe heart failure;
• Severe hepatic or renal dysfunction;
• Life expectancy less than 1 year;
• Prior PCI or CABG;
• Contraindications of using anticoagulation or antiplatelet drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

thrombus aspiration with PCI

Experimental group

Description:

patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI)

Treatment:

Procedure: percutaneous coronary intervention (PCI)

Device: thrombus aspiration

PCI alone

Active Comparator group

Description:

patients will receive percutaneous coronary intervention (PCI) alone including stent implantation

Treatment:

Procedure: percutaneous coronary intervention (PCI)