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

NCT04580706 | Unknown DMC

• 1 other identifier: 2020-P2-097-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ACS; Frail Elderly Syndrome; Elderly Patient

Outcome Measures

Primary Outcomes (4)

• Death

  All-cause death and cardiac death events

  During hospitalization, assessed up to 2 months

• 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

• Death

  All-cause death and cardiac death events

  1 year

• 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

Interventions

this is an observational study with none intervention OTHER

this is an observational study with none intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This registry will include consecutive patients age ≥65 years admitted for ACS

You may qualify if:

• Elderly participants over 65
• Clinical diagnosis of acute coronary syndrome
• Must be able to follow-up
• Sign in the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

Central Study Contacts

Sun Ying, MD

CONTACT

010-63137726; sunying@bfh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department geriatrics, Beijing Friendship Hospital

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 8, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

CN (1)