NCT05593822

Brief Summary

Aim of the work: Primary aim; is to assess relation between non invasive ECG findings, Tpe interval and QRS width and MBG in in patients with successful PCI in patients with STEMI. Secondary aim; is to assess impact of Tpe, QRS width and MBG on in hospital outcome

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

October 9, 2022

Last Update Submit

October 25, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • QRS width changes before and after PCI

    All the patients will be suspected to the following Electrocardiogram At admission and 90 minutes after the PCI, -QRS complex will be measured from the start to the end of the complex,(in milli-seconds)

    6 month

  • Tpe interval changes before and after PCI

    All the patients will be suspected to the following Electrocardiogram At admission and 90 minutes after the PCI, -Tpe interval will be measured from the peak of T wave to the end of it (in milli-seconds)

    6 month

  • MBG during PCI .

    primary PCI The contrast density in the distal myocardial region of the IRA is graded in comparison with the blush of non-IRA myocardial regions on cine film at 25 frames per second on the best projection along at least 3 cardiac cycles duration to ensure washout. * Patients with no myocardial blush are graded as MBG 0, * those with minimal myocardial blush are graded as MBG 1, * those with moderate myocardial blush are graded as MBG 2 * and patients with normal myocardial blush are graded as MBG 3.

    1 year

Secondary Outcomes (1)

  • left ventricular function

    1 year

Study Arms (1)

patient with STEMI

OTHER
Procedure: primary percutaneous intervention

Interventions

percutaneous catheterization through peripheral arteries to coronary arteries

patient with STEMI

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Typical ongoing ischemic chest pain for \>30 minutes
  • ST elevation ≥1mm in ≥2 contiguous leads (2 mm for pericordial leads)
  • Successful primary PCI (patent infarct related artery)

You may not qualify if:

  • Patients with known bundle branch block
  • Patients with advanced degree of atrioventricular block or electrolyte disturbances.
  • Permanent pacemaker
  • Cardiomyopathies, chronic kidney disease.
  • Previously revascularized patients either by PCI or CABG surgery

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

October 9, 2022

First Posted

October 25, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

October 27, 2022

Record last verified: 2022-10