NCT05097755

Brief Summary

To find out if the time delays between the first medical contacts till the device has an impact on LV functions estimated by transthoracic Echocardiography and if it's correlated to heart failure incidence in non-diabetic patients with STEMI treated with primary PCI

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
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

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

October 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

October 17, 2021

Last Update Submit

January 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • to what extent could the time be relevant to the incidence of Heart failure

    is the time delay correlated with LV functions and heart failure incidence?!

    baseline

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* All patients will be subjected to: * Calculation of time from the first medical contact to time of primary PCI. * Full history taking: including age, sex, history of HTN, Smoking, dyslipidemia, IHD

You may qualify if:

  • Subjects with anterior STEMI according to ESC guidelines 2017.
  • Subjects undergoing PPCI for the first time .
  • Non diabetic patients.

You may not qualify if:

  • Patients with previous PCI.
  • Patients with previous CABG.
  • Patients with TIMI flow II or less .
  • Cardiogenic shock.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident physician

Study Record Dates

First Submitted

October 17, 2021

First Posted

October 28, 2021

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

October 1, 2024

Last Updated

January 25, 2023

Record last verified: 2023-01