Thrombus Aspiration in Patients With STEMI

Phase 4

• Conditions: ST-segment Elevation Myocardial Infarction
• Interventions: Procedure: percutaneous coronary intervention (PCI); Device: thrombus aspiration

• Registration Number: NCT02606435
• Lead Sponsor: Xijing Hospital

Brief Summary

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).

Detailed 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.

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-12
• Last Update Submitted: 2015-11-12
• Study First Posted: 2015-11-17
• Last Update Posted: 2015-11-17
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCI alone	percutaneous coronary intervention (PCI)	patients will receive percutaneous coronary intervention (PCI) alone including stent implantation
thrombus aspiration with PCI	thrombus aspiration	patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI)
thrombus aspiration with PCI	percutaneous coronary intervention (PCI)	patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI)

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	1 year	number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure

Secondary Outcome Measures

Name	Time	Method
Number of participants with stent thrombosis	1 year	number of participants with stent thrombosis
left ventricular function	1 year	left ventricular ejection fraction evaluated by ultrasound
6-minute walk distance (6MWD)	1 year	6-minute walk distance (6MWD)
Number of participants with target vessel revascularization	1 year	number of participants with target vessel revascularization
Seattle Angina Questionnaire scores	1 year	Seattle Angina Questionnaire scores

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China