NCT03841487

Brief Summary

Patients who were diagnosed with ST-elevation myocardial infarction (STEMI) and received primary percutaneous coronary intervention (PPCI) from July 2009 to December 2011 were identified from the National Health Insurance Research Database of Taiwan. The investigators compared the 1-year outcomes of patients with STEMI who received aspiration thrombectomy during PPCI vs. those who received PPCI alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

February 12, 2019

Last Update Submit

February 13, 2019

Conditions

ST Elevation Myocardial Infarction

Keywords

ST-elevation myocardial infarctionThrombectomyMortalityStrokePhysician volume

Outcome Measures

Primary Outcomes (4)

  • Incidence rate of all-cause mortality at 30 days

    The total number of death during the follow-up period divided by the person-months at risk

    30 days from the date of primary percutaneous coronary intervention

  • Incidence rate of stroke at 30 days

    The total number of stroke events during the follow-up period divided by the person-months at risk

    30 days from the date of primary percutaneous coronary intervention

  • Incidence rate of all-cause mortality at 1 year

    The total number of death during the follow-up period divided by the person-months at risk

    1 year from the date of primary percutaneous coronary intervention

  • Incidence rate of stroke at 1 year

    The total number of stroke events during the follow-up period divided by the person-months at risk

    1 year from the date of primary percutaneous coronary intervention

Study Arms (2)

Aspiration thrombectomy

In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI).

Device: Aspiration thrombectomy

PCI alone

In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.

Interventions

Aspiration thrombectomyDEVICE

In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI). In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.

Also known as: Percutaneous coronary intervention
Aspiration thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ST elevation myocardial infarction who received primary percutaneous coronary intervention

You may qualify if:

  • Patients with ST elevation myocardial infarction

You may not qualify if:

  • Missing data on sex or discharge date
  • Aged less than 18 years
  • Previous stroke
  • Patients receiving thrombolytic therapy
  • Patients who did not undergo PPCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionStroke

Interventions

ThrombectomyPercutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresMinimally Invasive Surgical Procedures

Study Officials

  • Ying-Chang Tung

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Individual participant data is encrypted and is not allowed to share based on the regulations of the National Health Insurance Research Database of Taiwan.

Locations

TW(1)