NCT04332250

Brief Summary

evaluate the influence of incomplete revascularization during the index hospitalization on in-hospital and long-term outcomes in STEMI patients undergoing PPCI in Assiut University heart hospital.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

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, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3.9 years

First QC Date

March 31, 2020

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mace

    All the patients will be reviewed for during hospital admission to record major acute cardiac events (MACE). Only the most serious event of major adverse cardiac events will be used to calculate the cumulative major adverse cardiac events per patient according to the following sequence: (death \> heart failure \> recurrent non-fatal MI \> serious secondary arrhythmia necessitating DC shock\> recurrent or refractory angina. MACE will be reported according to the standard definitions

    between January 2016 to December 2019 were recruited

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Patients aged \>18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations

You may qualify if:

  • All Patients aged \>18 years with STEMI admitted to Assiut University Heart hospital and underwent successful PPCI between January 2016 to December 2019 were recruited. Selection of patients for primary PCI was as per guideline recommendations.

You may not qualify if:

  • Patients with incomplete data.
  • Patients with previous coronary artery bypass grafting (CABG).
  • Patients presenting with cardiogenic shock, cardiac arrest or pulmonary edema.
  • Mechanical complications of MI; namely VSD, wall rupture, mitral regurgitation secondary to papillary muscle or chordal rupture.
  • Patients with unsuccessful PPCI with a final TIMI flow ≤ I in infarct related artery.
  • Patients with a significant co-morbidity reducing life expectancy to \<1 year as patients with advanced liver diseases, cerebrovascular diseases, malignancy and chronic lung diseases that could affect patient prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

April 3, 2020

Record last verified: 2020-04