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Thrombus Aspiration in Patients With STEMI

NCT ID: NCT02606435

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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ST-segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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thrombus aspiration with PCI

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

Group Type EXPERIMENTAL

percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

percutaneous coronary intervention (PCI) by stent implantation

thrombus aspiration

Intervention Type DEVICE

thrombus aspiration with export catheter

PCI alone

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

Group Type ACTIVE_COMPARATOR

percutaneous coronary intervention (PCI)

Intervention Type PROCEDURE

percutaneous coronary intervention (PCI) by stent implantation

Interventions

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percutaneous coronary intervention (PCI)

percutaneous coronary intervention (PCI) by stent implantation

Intervention Type PROCEDURE

thrombus aspiration

thrombus aspiration with export catheter

Intervention Type DEVICE

Other Intervention Names

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primary percutaneous coronary intervention (PCI) export catheter

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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sunddong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

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Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

[email protected]
86 29 84775183

Facility Contacts

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Dongdong Sun, M.D.,Ph.D

Role: primary

[email protected]
86 18691569930

Other Identifiers

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SEED

Identifier Type: -

Identifier Source: org_study_id