Thrombus Aspiration in Patients With STEMI

Xijing Hospital300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

ST-segment Elevation Myocardial Infarction

Interventions

percutaneous coronary intervention (PCI)PROCEDURE

percutaneous coronary intervention (PCI) by stent implantation

thrombus aspirationDEVICE

thrombus aspiration with export catheter

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xijing hospital

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Major adverse cardiac events

number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure

Time frame: 1 year

Secondary Outcomes

Number of participants with stent thrombosis

number of participants with stent thrombosis

Time frame: 1 year

Number of participants with target vessel revascularization

number of participants with target vessel revascularization

Time frame: 1 year

left ventricular function

left ventricular ejection fraction evaluated by ultrasound

Time frame: 1 year

Seattle Angina Questionnaire scores

Time frame: 1 year

6-minute walk distance (6MWD)

Time frame: 1 year

Central Contacts

Dongdong Sun, M.D.,Ph.D.

CONTACT

86 29 84775183 wintersun3@gmail.com

Data from ClinicalTrials.gov

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