Thrombus Aspiration in Patients With STEMI

Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)

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).

Study Overview

• Status: Unknown
• Conditions: ST-segment Elevation Myocardial Infarction
• Intervention / Treatment: Procedure: percutaneous coronary intervention (PCI); Device: thrombus aspiration

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: thrombus aspiration with PCI; patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI)	Procedure: percutaneous coronary intervention (PCI); percutaneous coronary intervention (PCI) by stent implantation; Other Names: primary percutaneous coronary intervention (PCI); Device: thrombus aspiration; thrombus aspiration with export catheter; Other Names: export catheter
Active Comparator: PCI alone; patients will receive percutaneous coronary intervention (PCI) alone including stent implantation	Procedure: percutaneous coronary intervention (PCI); percutaneous coronary intervention (PCI) by stent implantation; Other Names: primary percutaneous coronary intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 12, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: SEED