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Thrombus Aspiration in Patients With STEMI

Primary Purpose

ST-segment Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
percutaneous coronary intervention (PCI)
thrombus aspiration
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

thrombus aspiration with PCI

PCI alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2015
Last Updated
November 12, 2015
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02606435
Brief Title
Thrombus Aspiration in Patients With STEMI
Official Title
Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
thrombus aspiration with PCI
Arm Type
Experimental
Arm Description
patient will receive manual thrombus aspiration with percutaneous coronary intervention (PCI)
Arm Title
PCI alone
Arm Type
Active Comparator
Arm Description
patients will receive percutaneous coronary intervention (PCI) alone including stent implantation
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary intervention (PCI)
Other Intervention Name(s)
primary percutaneous coronary intervention (PCI)
Intervention Description
percutaneous coronary intervention (PCI) by stent implantation
Intervention Type
Device
Intervention Name(s)
thrombus aspiration
Other Intervention Name(s)
export catheter
Intervention Description
thrombus aspiration with export catheter
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
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 Outcome Measure Information:
Title
Number of participants with stent thrombosis
Description
number of participants with stent thrombosis
Time Frame
1 year
Title
Number of participants with target vessel revascularization
Description
number of participants with target vessel revascularization
Time Frame
1 year
Title
left ventricular function
Description
left ventricular ejection fraction evaluated by ultrasound
Time Frame
1 year
Title
Seattle Angina Questionnaire scores
Description
Seattle Angina Questionnaire scores
Time Frame
1 year
Title
6-minute walk distance (6MWD)
Description
6-minute walk distance (6MWD)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongdong Sun, M.D.,Ph.D.
Phone
86 29 84775183
Email
wintersun3@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongdong Sun, M.D.,Ph.D.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongdong Sun, M.D.,Ph.D
Phone
86 18691569930
Email
wintersun3@gmail.com

12. IPD Sharing Statement

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Thrombus Aspiration in Patients With STEMI

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