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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04580706
Other study ID # 2020-P2-097-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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