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

October 7, 2020 updated by: Sun Ying, Beijing Friendship Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 010
        • Recruiting
        • Beijing Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-P2-097-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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