NCT04278911

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 19, 2020

Last Update Submit

February 19, 2020

Conditions

Acute Coronary SyndromeCognitive ImpairmentElderly

Outcome Measures

Primary Outcomes (1)

  • MACE (major adverse cardiovascular events)

    Myocardial infarction, revascularization, stroke, cardiac death, all cause of death

    12 months

Secondary Outcomes (2)

  • Cognitive level decline

    12 months

  • Cognitive level decline

    12 months

Study Arms (1)

Participates

This is an observational study

Diagnostic Test: MMSE and MoCA

Interventions

MMSE and MoCADIAGNOSTIC_TEST

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

Participates

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (4)

  • Saczynski JS, McManus DD, Waring ME, Lessard D, Anatchkova MD, Gurwitz JH, Allison J, Ash AS, McManus RH, Parish DC, Goldberg RJ, Kiefe CI. Change in Cognitive Function in the Month After Hospitalization for Acute Coronary Syndromes: Findings From TRACE-CORE (Transition, Risks, and Actions in Coronary Events-Center for Outcomes Research and Education). Circ Cardiovasc Qual Outcomes. 2017 Dec;10(12):e001669. doi: 10.1161/CIRCOUTCOMES.115.001669.

    PMID: 29237744BACKGROUND

  • Iadecola C, Yaffe K, Biller J, Bratzke LC, Faraci FM, Gorelick PB, Gulati M, Kamel H, Knopman DS, Launer LJ, Saczynski JS, Seshadri S, Zeki Al Hazzouri A; American Heart Association Council on Hypertension; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Stroke Council. Impact of Hypertension on Cognitive Function: A Scientific Statement From the American Heart Association. Hypertension. 2016 Dec;68(6):e67-e94. doi: 10.1161/HYP.0000000000000053. Epub 2016 Oct 10.

    PMID: 27977393BACKGROUND

  • Sundboll J, Horvath-Puho E, Adelborg K, Schmidt M, Pedersen L, Botker HE, Henderson VW, Sorensen HT. Higher Risk of Vascular Dementia in Myocardial Infarction Survivors. Circulation. 2018 Feb 6;137(6):567-577. doi: 10.1161/CIRCULATIONAHA.117.029127. Epub 2017 Oct 12.

    PMID: 29025764BACKGROUND

  • Gu SZ, Beska B, Chan D, Neely D, Batty JA, Adams-Hall J, Mossop H, Qiu W, Kunadian V. Cognitive Decline in Older Patients With Non- ST Elevation Acute Coronary Syndrome. J Am Heart Assoc. 2019 Feb 19;8(4):e011218. doi: 10.1161/JAHA.118.011218.

    PMID: 30773118BACKGROUND

MeSH Terms

Conditions

Acute Coronary SyndromeCognitive Dysfunction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Yunli Xing, Dr.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongwei Li, Prof.

CONTACT

0086 10 63139780lhw19656@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 20, 2020

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

June 30, 2022

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

CN(1)