Thrombus Aspiration in Patients With STEMI

ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02606435
• Other study ID #: SEED
• Status: Recruiting
• Phase: Phase 4
• First received: November 11, 2015
• Last updated: November 12, 2015
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2015
• Source: Xijing Hospital
• Contact: Dongdong Sun, M.D.,Ph.D.
• Phone: 86 29 84775183
• Email: wintersun3[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

Procedure:
• percutaneous coronary intervention (PCI)
percutaneous coronary intervention (PCI) by stent implantation

Device:
• thrombus aspiration
thrombus aspiration with export catheter

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of participants with stent thrombosis	number of participants with stent thrombosis	1 year	No
Secondary	Number of participants with target vessel revascularization	number of participants with target vessel revascularization	1 year	No
Secondary	left ventricular function	left ventricular ejection fraction evaluated by ultrasound	1 year	No
Secondary	Seattle Angina Questionnaire scores	Seattle Angina Questionnaire scores	1 year	No
Secondary	6-minute walk distance (6MWD)	6-minute walk distance (6MWD)	1 year	No