FrailtyNCT07190274
Prospective Observational Cohort Study on Impact of Frailty on Risk Prediction, Treatment Strategies, and Short-Term Outcomes in Patients With Acute Coronary Syndrome
An observational study of Frailty and ACS (Acute Coronary Syndrome), run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, ACS (Acute Coronary Syndrome), MACE
- How many people
- 645 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jun 2028
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Elderly: Age ≥65 years .
- STEMI/NSTEMI (ESC/ACC criteria)
- Presentation <24h of symptom onset
Who cannot join
- Terminal illness (life expectancy <1 month)
- Severe dementia precluding assessment
- Declined consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Frailty on Risk Prediction, Treatment Strategies, and Short-Term Outcomes in Patients With Acute Coronary Syndrome
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.
Read the detailed description
Frailty is a geriatric syndrome used to define elderly patients with impaired resistance to stressors due to a decline in physiological reserve. Frailty has become increasingly relevant in the field of cardiovascular medicine, not only for the increased aging of the population, but also for the emerging evidence linking CVD and frailty both at the mechanistic level and the epidemiologic level.
The elderly represent an increasing proportion of ACS patients, but they are often excluded from or underrepresented in clinical trials. A thorough assessment of older ACS patients is important, including the evaluation of frailty or comorbidity from the onset of hospitalization and extending to intervention, medications, and type and frequency of MACE. This strategy enables the delivery of a personalized approach for such a vulnerable subgroup.
While established ACS risk models like the GRACE and TIMI scores guide treatment decisions and predict outcomes, they do not account for frailty, an independent, multidimensional predictor of adverse events in the elderly.
Evaluating both the predictive value of frailty and its effect on treatment decisions and outcomes provides comprehensive insight into its clinical relevance in ACS.
- Conditions
- Frailty, ACS (Acute Coronary Syndrome), MACE, GRACE Score
- Keywords
- frailty, ACS
- Medical subject headings
- Frailty, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day Major Adverse Cardiovascular Events (MACE)
Composite outcome including cardiovascular death, non-fatal myocardial infarction, stroke, or urgent revascularization, stratified by frailty status.
Measured: 30 days after index admission
Secondary outcomes (2)
All-cause mortality
Mortality occurring during index hospitalization
Measured: 30 days after index admission
Acute Kidney Injury (AKI)
AKI defined according to KDIGO criteria (increase in serum creatinine ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days).
Measured: 30 days after index admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Gamal Nabih Habib, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190274
- Sponsor's protocol ID
- frailty in ACS patients
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Frailty on Risk Prediction, Treatment Strategies, and Short-Term Outcomes in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07190274
- Acronym / sponsor ID
- frailty in ACS patients
- Conditions
- Frailty, ACS (Acute Coronary Syndrome), MACE, GRACE Score
- Keywords
- frailty, ACS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 645 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Frailty is a geriatric syndrome used to define elderly patients with impaired resistance to stressors due to a decline in physiological reserve. Frailty has become increasingly relevant in the field of cardiovascular medicine, not only for the increased aging of the population, but also for the emerging evidence linking CVD and frailty both at the mechanistic level and the epidemiologic level.
The elderly represent an increasing proportion of ACS patients, but they are often excluded from or underrepresented in clinical trials. A thorough assessment of older ACS patients is important, including the evaluation of frailty or comorbidity from the onset of hospitalization and extending to intervention, medications, and type and frequency of MACE. This strategy enables the delivery of a personalized approach for such a vulnerable subgroup.
While established ACS risk models like the GRACE and TIMI scores guide treatment decisions and predict outcomes, they do not account for frailty, an independent, multidimensional predictor of adverse events in the elderly.
Evaluating both the predictive value of frailty and its effect on treatment decisions and outcomes provides comprehensive insight into its clinical relevance in ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Elderly: Age ≥65 years .
- STEMI/NSTEMI (ESC/ACC criteria)
- Presentation <24h of symptom onset
Key exclusion criteria (3 listed)
- Terminal illness (life expectancy <1 month)
- Severe dementia precluding assessment
- Declined consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days after index admission
Composite outcome including cardiovascular death, non-fatal myocardial infarction, stroke, or urgent revascularization, stratified by frailty status.
2 secondary outcomes
All-cause mortality
Time frame: 30 days after index admission
Acute Kidney Injury (AKI)
Time frame: 30 days after index admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- 1\. Cepas-Guillén P, Diez-Villanueva P. One-year clinical events according to frailty in older patients with non-ST elevation acute coronary syndrome undergoing coronary angiography: an analysis of the IMPACT-TIMING-GO study. J Geriatr Cardiol. 2025;22(1)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and ACS (Acute Coronary Syndrome), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fady Gamal Habib (+201004721578, fady.17289635@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Major Adverse Cardiovascular Events (MACE) (time frame: 30 days after index admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.