Effect of CI on Prognosis in the Elderly Patients With ACS (CIACS)

February 19, 2020 updated by: Hongwei Li, MD, Beijing Friendship Hospital

Effect of Cognitive Impairment (CI) on Prognosis in the Elderly Patients With Acute Coronary Syndrome (ACS)

This study aims to investigate the incidence and characteristics of cognitive Impairment(CI) in the elderly patients with acute coronary syndrome (ACS), and to determine whether CI are predictive of the prognosis of major adverse cardiovascular events (MACE) and mortality.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • 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

Older patients (≥65yr) admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed ACS diagnosis

Description

Inclusion Criteria:

  • ≥65yr
  • Confirmed ACS diagnosis （include unstable angina, ST-segment elevation myocardial infarction and Non ST-segment elevation myocardial infarction）
  • fulfilled MMSE or MoCA
  • patients agreed and provided informed consent

Exclusion Criteria:

  • Type 2 myocardial infarction and Acute nonischemic myocardial injury
  • past history of malignant tumors
  • Past history of stroke or dementia
  • Hepatic insufficiency (ALT>8ULN or ALT>3ULN and TBIL>2ULN)
  • Renal insufficiency (GFR<15 ml/min/1.73m2)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participates
This is an observational study
Diagnostic test: MMSE and MoCA
This is an observational study. All the patients evaluate with MMSE (Mini-mental State Examination) and MoCA (Montreal Cognitive Assessment), and investigate the incidence and characteristics of cognitive and MACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (major adverse cardiovascular events)
Time Frame: 12 months
Myocardial infarction, revascularization, stroke, cardiac death, all cause of death
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive level decline
Time Frame: 12 months
Evaluate with MMSE (Mini-mental State Examination)
12 months
Cognitive level decline
Time Frame: 12 months
Evaluate MoCA (Montreal Cognitive Assessment).
12 months

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Yunli Xing, Dr., Beijing Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH--CI and ACS

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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