Effect of CI on Prognosis in the Elderly Patients With ACS

Acute Coronary Syndrome Clinical Trial

— CIACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278911
• Other study ID #: BFH--CI and ACS
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2020
• Source: Beijing Friendship Hospital
• Contact: Hongwei Li, Prof.
• Phone: 0086 10 63139780
• Email: lhw19656[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cognitive Dysfunction
• Cognitive Impairment
• Elderly
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. Epub 2016 Oct 10. Review. — View Citation

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). pii: e001669. doi: 10.1161/CIRCOUTCOMES.115.001669. — View Citation

Sundbøll J, Horváth-Puhó E, Adelborg K, Schmidt M, Pedersen L, Bøtker HE, Henderson VW, Toft Sørensen H. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (major adverse cardiovascular events)	Myocardial infarction, revascularization, stroke, cardiac death, all cause of death	12 months
Secondary	Cognitive level decline	Evaluate with MMSE (Mini-mental State Examination)	12 months
Secondary	Cognitive level decline	Evaluate MoCA (Montreal Cognitive Assessment).	12 months