Clinical trial NCT04278911: Effect of CI on Prognosis in the Elderly Patients With ACS
Official title: Effect of Cognitive Impairment (CI) on Prognosis in the Elderly Patients With Acute Coronary Syndrome (ACS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Cognitive Impairment
Elderly
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients (≥65yr) admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed ACS diagnosis

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.


Eligibility criteria: 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)

Primary outcomes:
measure: MACE (major adverse cardiovascular events)
timeFrame: 12 months
Secondary outcomes:
measure: Cognitive level decline
timeFrame: 12 months
measure: Cognitive level decline
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Yunli Xing, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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):e001669. doi: 10.1161/CIRCOUTCOMES.115.001669.
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. doi: 10.1161/HYP.0000000000000053. Epub 2016 Oct 10.
citation: 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.
citation: 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.