NCT05392777

Brief Summary

The aim of this study is to evaluate the utility of residual syntax score after PCI of the culprit vessel for patients with AMI (STEMI or NSTEMI) to predict 6-months clinical outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

May 23, 2022

Last Update Submit

February 7, 2023

Conditions

Myocardial Infarction

Keywords

Residual syntax scoreSTEMINSTEMIMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Composite of major adverse cardiovascular events (MACE).

    Composite of MACE (defined as; CV death, non-fatal MI, non-fatal stroke)

    6 months

Secondary Outcomes (4)

  • Rates of myocardial infarction

    6 months

  • Rates of cerebrovascular stroke

    6 months

  • Rates of ischaemia-deriven unplanned revascularization

    6 months

  • Rates of heart failure manifestations

    6 months

Interventions

Residual syntax scoreDIAGNOSTIC_TEST

residual syntax score will be calculated as the conventional syntax score from the web based tool, but subtract the score of the culprit lesion(s) that are fixed (stented) in the index procedure.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Human participants of both genders, above the age of 18 years, with acute myocardial infarction (STEMI and NSTEMI) coming for primary or urgent PCI, who accept to participate to this observational study.

You may qualify if:

  • \- Acute myocardial infarction (STEMI or NSTEMI)

You may not qualify if:

  • Refusal to participate in the study.
  • In case of NSTEMI, patients with unrecognizable culprit lesion will be excluded.
  • Patients with previous coronary bypass surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University hospitals

Cairo, 11815, Egypt

Location

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ahmad Samir, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

November 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

EG(1)