NCT02606435

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

November 11, 2015

Last Update Submit

November 12, 2015

Conditions

ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Number of participants with stent thrombosis

    1 year

  • Number of participants with target vessel revascularization

    1 year

  • left ventricular function

    1 year

  • Seattle Angina Questionnaire scores

    1 year

  • 6-minute walk distance (6MWD)

    1 year

Study Arms (2)

thrombus aspiration with PCI

EXPERIMENTAL

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

Procedure: percutaneous coronary intervention (PCI)Device: thrombus aspiration

PCI alone

ACTIVE COMPARATOR

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

Procedure: percutaneous coronary intervention (PCI)

Interventions

percutaneous coronary intervention (PCI)PROCEDURE

percutaneous coronary intervention (PCI) by stent implantation

Also known as: primary percutaneous coronary intervention (PCI)
PCI alonethrombus aspiration with PCI
thrombus aspirationDEVICE

thrombus aspiration with export catheter

Also known as: export catheter
thrombus aspiration with PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Dongdong Sun, M.D.,Ph.D.

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

86 29 84775183wintersun3@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 17, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

CN(1)