NCT04104048

Brief Summary

To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

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

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 20, 2020

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

September 24, 2019

Last Update Submit

May 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short term Outcome of Primary Percutaneous Coronary Intervention in Ostial Versus Non-Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infarction

    To compare short-term clinical outcomes of primary PCI between the ostial LAD-AMI and the non-ostial LAD-AMI. The primary endpoint was the major cardiovascular events (MACE) defined as being the composite of cardiac death, AMI, stent thrombosis

    baseline

Study Arms (1)

patients who were diagnosed as Anterior STEMI

1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology. 2. Onset of maximal intensity of chest pain within 12 hours before procedure

Eligibility Criteria

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

1. Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology. 2. Onset of maximal intensity of chest pain within 12 hours before procedure

You may qualify if:

  • Patients who were diagnosed as Anterior STEMI according to criteria developed by the European Society of Cardiology.
  • Onset of maximal intensity of chest pain within 12 hours before procedure

You may not qualify if:

  • Patients presenting with Previous PCI to LAD.
  • Patients presenting with Previous CABG.
  • Patients presenting with NSTEMI ACS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yamamoto K, Sakakura K, Akashi N, Watanabe Y, Noguchi M, Taniguchi Y, Wada H, Momomura SI, Fujita H. Comparison of Clinical Outcomes between the Ostial Versus Non-Ostial Culprit in Proximal Left Anterior Descending Artery Acute Myocardial Infarction. Int Heart J. 2019 Jan 25;60(1):37-44. doi: 10.1536/ihj.18-067. Epub 2018 Nov 20.

    PMID: 30464130BACKGROUND

Study Officials

  • youstina marzook, Msc

    study principal investigator Assiut university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yehia taha, professor

CONTACT

khaled mohammed, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principel investigator

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

October 1, 2023

Last Updated

May 20, 2020

Record last verified: 2019-09