NCT07190274

Brief Summary

we aim :

  • To evaluate how frailty influences acute management decisions (invasive vs conservative strategy) in ACS patients and whether it independently affects short-term outcomes.
  • To determine whether adding frailty assessment to existing ACS risk prediction models improves the prediction of 30-day mortality and major adverse cardiovascular events (MACE) in elderly ACS patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
645

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

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 Progress17%
Dec 2025Jun 2028

First Submitted

Initial submission to the registry

September 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 16, 2025

Last Update Submit

September 22, 2025

Conditions

FrailtyACS (Acute Coronary Syndrome)MACEGRACE Score

Keywords

frailtyACS

Outcome Measures

Primary Outcomes (1)

  • 30-day Major Adverse Cardiovascular Events (MACE)

    Composite outcome including cardiovascular death, non-fatal myocardial infarction, stroke, or urgent revascularization, stratified by frailty status.

    30 days after index admission

Secondary Outcomes (2)

  • All-cause mortality

    30 days after index admission

  • Acute Kidney Injury (AKI)

    30 days after index admission

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients aged ≥65 years presenting with STEMI or NSTEMI within 24 hours of symptom onset, excluding those with terminal illness, severe dementia, or refusal of consent.

You may qualify if:

  • Elderly: Age ≥65 years .
  • STEMI/NSTEMI (ESC/ACC criteria)
  • Presentation \<24h of symptom onset

You may not qualify if:

  • Terminal illness (life expectancy \<1 month)
  • Severe dementia precluding assessment
  • Declined consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

FrailtyAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Fady Gamal Habib

CONTACT

+201004721578fady.17289635@med.aun.edu.eg

Ahmed Abdelgaleel

CONTACT

+201005015156Ahmed.galeel@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2025

First Posted

September 24, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

September 24, 2025

Record last verified: 2025-09