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Thrombus Aspiration in Patients With STEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02606435
Recruitment Status : Unknown
Verified November 2015 by sunddong, Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
sunddong, 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).

Condition or disease Intervention/treatment Phase
ST-segment Elevation Myocardial Infarction Procedure: percutaneous coronary intervention (PCI) Device: thrombus aspiration Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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 Name: primary percutaneous coronary intervention (PCI)

Device: thrombus aspiration
thrombus aspiration with export catheter
Other Name: 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 Name: primary percutaneous coronary intervention (PCI)




Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 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 :
  1. Number of participants with stent thrombosis [ Time Frame: 1 year ]
    number of participants with stent thrombosis

  2. Number of participants with target vessel revascularization [ Time Frame: 1 year ]
    number of participants with target vessel revascularization

  3. left ventricular function [ Time Frame: 1 year ]
    left ventricular ejection fraction evaluated by ultrasound

  4. Seattle Angina Questionnaire scores [ Time Frame: 1 year ]
    Seattle Angina Questionnaire scores

  5. 6-minute walk distance (6MWD) [ Time Frame: 1 year ]
    6-minute walk distance (6MWD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606435


Contacts
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Contact: Dongdong Sun, M.D.,Ph.D. 86 29 84775183 wintersun3@gmail.com

Locations
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China, Shaanxi
Xijing hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Dongdong Sun, M.D.,Ph.D    86 18691569930    wintersun3@gmail.com   
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Dongdong Sun, M.D.,Ph.D. Fourth Military Medical University

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Responsible Party: sunddong, Principal Investigator, Xijing Hospital
ClinicalTrials.gov Identifier: NCT02606435    
Other Study ID Numbers: SEED
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases