The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome

Frail Elderly Syndrome Clinical Trial

Official title:

The Effect of Frailty and Other Geriatric Syndromes on the Prognosis of Elderly Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04580706
• Other study ID #: 2020-P2-097-01
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Beijing Friendship Hospital
• Contact: Sun Ying, MD
• Phone: 010-63137726
• Email: sunying[@]bfh.com.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a prospective observational clinical trail which will recruit 1000-1500 participants over 65 years with frailty and acute coronary syndrome (ACS) in Beijing Friendship hospital. The investigators will conduct frailty assessment (FRAIL scale, CFS, SPPB), comorbidities, functional status (Barthel index, ADL, IADL), nutritional risk (MNA-SF), and then observe the clinical outcomes of elderly ACS participants with frailty. Then, the investigators will follow-up these participants separately in 1,3,6 and 12months, the anticipate follow-up time is 1 year. According to the follow-up results, investigators will evaluate the impact of frailty and other senile syndromes on the short-term and long-term prognosis of ACS, and develop a scoring system for the prognosis evaluation of elderly ACS participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Elderly participants over 65

• Clinical diagnosis of acute coronary syndrome

• Must be able to follow-up

• Sign in the informed consent

Exclusion Criteria:

• Myocardial infarction caused by other acute disease

• Mental disorders who cannot cooperate to complete the assessment

• Severe liver dysfunction, kidney disease (CKD 5), end-stage malignant tumor

• Totally disabled and bedridden

Related Conditions & MeSH terms

• ACS
• Acute Coronary Syndrome
• Elderly Patient
• Frail Elderly Syndrome
• Frailty
• Syndrome

Intervention

Other:
• this is an observational study with none intervention
this is an observational study with none intervention

Locations

Country	Name	City	State
China	Beijing Friendship hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All-cause death and cardiac death events	During hospitalization, assessed up to 2 months
Primary	Major Adverse Cardiac and Cerebrovascular events	Major Adverse Cardiac and Cerebrovascular events including heart failure, cardiac shock, malignant arrhythmia, myocardial infarction, revascularization, and cerebral infarction	During hospitalization, assessed up to 2 months
Primary	Death	All-cause death and cardiac death events	1 year
Primary	Major Adverse Cardiac and Cerebrovascular events	Major Adverse Cardiac and Cerebrovascular events including heart failure, cardiac shock, malignant arrhythmia, myocardial infarction, revascularization, and cerebral infarction	1 year