NCT03895983

Brief Summary

To compare the ST segment resolution after primary percutaneous coronary intervention (PPCI) with and without thrombus aspiration in patients with ST segment elevation myocardial infarction as ST segment resolution is the best indicator for the prediction of the outcome and MACE

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

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

First Submitted

Initial submission to the registry

March 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 24, 2019

Last Update Submit

March 28, 2019

Conditions

ST Segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • ST segment resolution

    ST segment resolution in relation to the procedure used in primary percutaneous coronary intervention

    Within 90 minutes after the procedure

Secondary Outcomes (1)

  • MACE

    one week

Study Arms (2)

Thrombus aspiration group

Will include 135 patients who will have PPCI with thrombus aspiration

Procedure: Percutaneous primary coronary intervention

Standard PPCI group

Will include 135 patients who will have PPCI without thrombus aspiration

Procedure: Percutaneous primary coronary intervention

Interventions

Percutaneous primary coronary interventionPROCEDURE

Percutaneous primary coronary intervention

Standard PPCI groupThrombus aspiration group

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

270 patients

You may qualify if:

  • patients with STEMI within 24 hours of chest pain.patients killip class 1 is included in this study
  • xclusion Criteria:
  • killip II-IV
  • Previous myocardial infarction
  • Patients with left bundle branch block
  • Patients with advanced cancer disease
  • Patients qith contraindications to anti-coagulation
  • Patients with sensitivity to clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 24, 2019

First Posted

March 29, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

March 29, 2019

Record last verified: 2019-03