FrailtyNCT07158788
Role of Frailty in Bleeding Risk Prediction in Acute Coronary Syndrome
An observational study of Frailty and Acute Coronary Syndrome, run by Assiut University.
Trial summary
Studying the incremental role of frailty in predicting in-hospital, short-term (30 days), and mid-term (6 months) bleeding in ACS patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Acute Coronary Syndrome, Bleeding
- How many people
- 850 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Sep 2027
- 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: Patients presenting with acute coronary syndrome ( STEMI and NSTEMI) and are older than 65 years
Who may be able to join
- - Patients must be suffering from acute coronary syndrome ( STEMI - NSTEMI ) at the time of recruitment
- - Patients must be older than 65 years
Who cannot join
- - Patients younger than 65 years
- - Refusal of participation
- - In - hospital death unrelated to bleeding
About this study
Official title: Incremental Value of Frailty Indices in Bleeding Risk Prediction Among Patients With Acute Coronary Syndrome
Studying the incremental role of frailty in predicting in-hospital, short-term (30 days), and mid-term (6 months) bleeding in ACS patients.
Read the detailed description
Potent platelet inhibition reduces the risk of thrombotic complications in patients with acute coronary syndromes. Unavoidably, the more potent platelet inhibition increases the risk of bleeding. Bleeding risk can be predicted using the ARC-HBR criteria, the CRUSADE score, ACUITY score, and PRECISE-DAPT score. These conventional risk scores incorporate clinical, laboratory and procedural variables but often overlook patient centered geriatric parameters such as frailty. Frailty is a multidimensional syndrome characterized by decreased reserves and diminished resistance to stressors. It can be assessed using Rockwoods clinical frailty scale, the frailty index, frailty domains and the Fried scale. The association between frailty and bleeding risk in ACS patients is still inadequately studied. We hypothesize that frailty indices would increase the discriminatory power of established standard bleeding risk scores, and would predict bleeding events among ACS patients.
- Conditions
- Frailty, Acute Coronary Syndrome, Bleeding
- Keywords
- Frailty, acute coronary syndrome, bleeding, bleeding risk prediction
- Medical subject headings
- Frailty, Acute Coronary Syndrome, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Academic Research Consortium ( BARC ) type 3 to 5
Type 3: Major bleeding (with subtypes) 3a: Overt bleeding plus hemoglobin drop of 3-5 g/dL, or Transfusion with ≤2 units of blood.
3b: Hemoglobin drop ≥5 g/dL, Cardiac tamponade, Bleeding requiring surgical intervention, or Bleeding requiring intravenous vasoactive agents. 3c: Intracranial hemorrhage (excluding microbleeds), Intraocular bleeding compromising vision.
Type 4: CABG-related bleeding Perioperative bleeding within 48 hours of coronary artery bypass grafting (CABG) and Reoperation for bleeding, ≥5 units of blood transfused, Chest tube output ≥2 L in 24 hours, or Cardiac tamponade.
Type 5: Fatal bleeding 5a: Probable fatal bleeding (no autopsy or imaging confirmation). 5b: Definite fatal bleeding (confirmed by autopsy or imaging)
Measured: Baseline
Secondary outcomes (1)
Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2
Type 0 : no bleeding Type 1: Bleeding that is not actionable and does not require medical attention Type 2 : Any bleeding that requires medical attention, hospitalization, or evaluation by a health care professional. but does not meet criteria for type 3, 4 or 5.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (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
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Hosny Labib Habib, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158788
- Sponsor's protocol ID
- Frailty Bleeding ACS
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Value of Frailty Indices in Bleeding Risk Prediction Among Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07158788
- Acronym / sponsor ID
- Frailty Bleeding ACS
- Conditions
- Frailty, Acute Coronary Syndrome, Bleeding
- Keywords
- Frailty, acute coronary syndrome, bleeding, bleeding risk prediction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 8 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.
Studying the incremental role of frailty in predicting in-hospital, short-term (30 days), and mid-term (6 months) bleeding in ACS patients.
Detailed description
Potent platelet inhibition reduces the risk of thrombotic complications in patients with acute coronary syndromes. Unavoidably, the more potent platelet inhibition increases the risk of bleeding. Bleeding risk can be predicted using the ARC-HBR criteria, the CRUSADE score, ACUITY score, and PRECISE-DAPT score. These conventional risk scores incorporate clinical, laboratory and procedural variables but often overlook patient centered geriatric parameters such as frailty. Frailty is a multidimensional syndrome characterized by decreased reserves and diminished resistance to stressors. It can be assessed using Rockwoods clinical frailty scale, the frailty index, frailty domains and the Fried scale. The association between frailty and bleeding risk in ACS patients is still inadequately studied. We hypothesize that frailty indices would increase the discriminatory power of established standard bleeding risk scores, and would predict bleeding events among ACS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients presenting with acute coronary syndrome ( STEMI and NSTEMI) and are older than 65 years
Key inclusion criteria (2 listed)
- - Patients must be suffering from acute coronary syndrome ( STEMI - NSTEMI ) at the time of recruitment
- - Patients must be older than 65 years
Key exclusion criteria (3 listed)
- - Patients younger than 65 years
- - Refusal of participation
- - In - hospital death unrelated to bleeding
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
Bleeding Academic Research Consortium ( BARC ) type 3 to 5
Time frame: Baseline
Type 3: Major bleeding (with subtypes) 3a: Overt bleeding plus hemoglobin drop of 3-5 g/dL, or Transfusion with ≤2 units of blood. 3b: Hemoglobin drop ≥5 g/dL, Cardiac tamponade, Bleeding requiring surgical intervention, or Bleeding requiring intravenous vasoactive agents. 3c: Intracranial hemorrhage (excluding microbleeds), Intraocular bleeding compromising vision. Type 4: CABG-related bleeding Perioperative bleeding within 48 hours of coronary artery bypass grafting (CABG) and Reoperation for bleeding, ≥5 units of blood transfused, Chest tube output ≥2 L in 24 hours, or Cardiac tamponade. Type 5: Fatal bleeding 5a: Probable fatal bleeding (no autopsy or imaging confirmation). 5b: Definite fatal bleeding (confirmed by autopsy or imaging)
1 secondary outcome
Bleeding Academic Research Consortium ( BARC ) type 0, 1 or 2
Time frame: Baseline
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 8 Sep 2025.
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and 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 2 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 8 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding Academic Research Consortium ( BARC ) type 3 to 5 (time frame: Baseline). 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 8 Sep 2025.