Acute Coronary SyndromeCIACSNCT04278911
Effect of CI on Prognosis in the Elderly Patients With ACS
An observational study of Acute Coronary Syndrome and Cognitive Impairment, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Cognitive Impairment, Elderly
- What is being tested?
- MMSE and MoCA
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older patients (≥65yr) admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed ACS diagnosis
Who may be able to join
- ≥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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Hongwei Li, M.D, 0086 10 63139780, lhw19656@sina.com
Yunli Xing, M.D, 0086 10 63139595, xingyunli1976@126.com
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome, Cognitive Impairment, Elderly
- Being tested
- MMSE and MoCA
- Medical subject headings
- Acute Coronary Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Participates | This is an observational study Receives: Diagnostic Test: MMSE and MoCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (major adverse cardiovascular events)
Myocardial infarction, revascularization, stroke, cardiac death, all cause of death
Measured: 12 months
Secondary outcomes (2)
Cognitive level decline
Evaluate with MMSE (Mini-mental State Examination)
Measured: 12 months
Cognitive level decline
Evaluate MoCA (Montreal Cognitive Assessment).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Li, MD, Beijing Friendship Hospital
- Investigators
- Yunli Xing, Dr., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278911
- Sponsor's protocol ID
- BFH--CI and ACS
- Acronym
- CIACS
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29237744Iadecola 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.
PubMed 27977393Sundboll 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.
PubMed 29025764Gu 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.
PubMed 30773118
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Impairment (CI) on Prognosis in the Elderly Patients With Acute Coronary Syndrome (ACS)
- ClinicalTrials.gov ID
- NCT04278911
- Acronym / sponsor ID
- CIACS / BFH--CI and ACS
- Conditions
- Acute Coronary Syndrome, Cognitive Impairment, Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participates | – | Diagnostic Test: MMSE and MoCAThis is an observational study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients (≥65yr) admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed ACS diagnosis
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMSE and MoCAThis 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 | Diagnostic test | Participates |
Primary outcome
MACE (major adverse cardiovascular events)
Time frame: 12 months
Myocardial infarction, revascularization, stroke, cardiac death, all cause of death
2 secondary outcomes
Cognitive level decline
Time frame: 12 months
Cognitive level decline
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 29237744Saczynski 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.
- Background: PubMed 27977393Iadecola 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.
- Background: PubMed 29025764Sundboll 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.
- Background: PubMed 30773118Gu 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.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunli Xing, Dr. principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Cognitive Impairment, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Li, Prof. (0086 10 63139780, lhw19656@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (major adverse cardiovascular events) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278911, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.