StrokePLATFORM-CVDNCT04775836
An EHR-based Platform To Facilitate Outcomes and Research Methods in Cerebrovascular Diseases
An observational study of Stroke and Cerebrovascular Diseases, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
In this protocol, the investigators present methods and preliminary results from the PLATFORM-CVD Study, an EHR-based multicenter cohort. This study will focus on assessing the distribution of major cerebrovascular diseases, determining the risk factors associated with disease incidence and worse in-hospital outcomes… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Cerebrovascular Diseases, Cerebral Infarction
- How many people
- 300,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2021
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Twenty-five hospitals were enrolled in the PLATFORM-CVD Study between January 1st, 2017 and May 20th, 2020. Hospitals were included if they: 1) had neurological wards; 2) were secondary or tertiary hospitals; 3) could admit at least 20 cerebrovascular disease patients every month.
Who may be able to join
- Patients were included in the registry if they were hospitalized with a primary diagnose of：
- cerebral infarction (I63)
- nontraumatic intracerebral hemorrhage (I61)
- nontraumatic subarachnoid hemorrhage (I60)
- transient cerebral ischemic attack and related syndromes (G45)
- intracranial and intraspinal phlebitis and thrombophlebitis (G08)
- vascular dementia (F01)
- other aneurysms (I72)
Who cannot join
- Patients diagnosed with other diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Meng Wang, PhD, 13261053863, wangmengpumc@163.com
Zi-Xiao Li, PhD
About this study
Official title: A Platform for Linking and Assessing To Facilitate Outcomes and Research Methods in CerebroVascular Diseases Using Electronic Health Records (PLATFORM-CVD)
In this protocol, the investigators present methods and preliminary results from the PLATFORM-CVD Study, an EHR-based multicenter cohort. This study will focus on assessing the distribution of major cerebrovascular diseases, determining the risk factors associated with disease incidence and worse in-hospital outcomes, as well as describing the quality of care. Data from this cohort will be used to develop suitable prediction models for cerebrovascular diseases using real-world data and to understand how outcomes for cerebrovascular diseases would change with quality improvement interventions.
Read the detailed description
Adherence to healthcare quality measures is needed to reduce the burden of cerebrovascular disease and improve clinical outcomes. Electronic health records (EHRs) can facilitate the standardization of care provision and the improvement of disease prediction and prevention. Although the EHRs in clinical settings are increasingly prevalent in China, they are rarely used for healthcare research. the investigators aimed to conduct an EHR-based registry study to improve the healthcare and outcomes for cerebrovascular diseases.
Twenty-four hospitals were enrolled in the PLATFORM-CVD Study in January 2018. Data collection began on February 1st, 2019. Historical data from January 2017 are abstracted first and prospective data are continuously reported until May 20th, 2020. Data were abstracted from the medical records, including hospital information system, laboratory information management system, and picture archiving and communication systems by an extract-transform-load tool. The EHR system included diagnostic information for cerebral infarctions (I63), nontraumatic intracerebral hemorrhages (I61), nontraumatic subarachnoid hemorrhages (I60), transient cerebral ischemic attacks and related syndromes (G45), intracranial and intraspinal phlebitis and thrombophlebitis (G08), vascular dementia (F01), and other aneurysms (I72). The quality of stroke care was assessed by 21 evidence-based performance measures. In-hospital outcomes were calculated including mortality, length of stay, and costs.
The PLATFORM-CVD Study leverages EHRs to better understand incident cerebrovascular diseases in China. Data from this cohort will serve as a unique platform for quality assessment and improvement for acute treatment and secondary prevention of cerebrovascular diseases, as well as in-hospital outcome risk predictions and health economic evaluations.
- Conditions
- Stroke, Cerebrovascular Diseases, Cerebral Infarction, Cerebral Hemorrhage, Transient Ischemic Attack, Subarachnoid Hemorrhage
- Keywords
- Healthcare Quality, Electronic Health Records, Cerebrovascular Diseases
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Cerebral Infarction, Cerebral Hemorrhage, Ischemic Attack, Transient, Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Patients who died during hospitalization due to cerebrovascular diseases
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Length of stay at hospital
The total days for a patients with cerebrovascular diseases at hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Costs
The total costs for a patients with cerebrovascular diseases at hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Secondary outcomes (21)
Rate of antiplatelet medication use
Rate of antiplatelet therapy during hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of dual antiplatelet medication use for non-disabling IS and TIA events
Rate of aspirin and clopidogrel therapy for ischemic cerebrovascular diseases (IS or TIA) during hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours
Patients at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression, warfarin sodium, and novel oral anticoagulant
Measured: 48 hours within hospitalization
Cerebrovascular assessment ≤ seven days
Cerebrovascular assessment (TCD, IVUS, brain CT or MR scan) within seven days of hospitalization
Measured: 7 days within hospitalization
Statin therapy for LDL ≥100 mg/dL during hospitalization
Lipid lowering agent prescribed during hospitalization if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication use for atrial fibrillation during hospitalization
Anticoagulation prescribed during hospitalization in patients with documented atrial fibrillation
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antithrombotic medication prescribtion at discharge
Antithrombotic therapy prescribed at discharge, including antiplatelet or anticoagulant therapy
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antihypertensive medication prescribtion for patients with hypertension at discharge
Antihypertension medication prescribed at discharge for patients with history of hypertension disease or hypertension disease documented during the hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of statin prescribtion for low-density lipoprotein≥100 mg/dL at discharge
Lipid lowering agent prescribed at discharge if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycaemia medication prescribtion for diabetes mellitus at discharge
Hypoglycemic medication prescribed at discharge for patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication prescribtion for atrial fibrillation at discharge
Anticoagulation prescribed at discharge in patients with documented atrial fibrillation
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombolytic therapy
Intravenous r-tPA in IS patients
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombectomy therapy
Thrombectomy therapy for IS patients
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for ICH
Patients with ICH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression.
Measured: 48 hours within hospitalization
Rate of antihypertensive medicine use for ICH patients with hypertension at discharge
Antihypertension medication prescribed at discharge for ICH patients with history of hypertension disease or hypertension disease documented during the hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycemia medication use for ICH patients with diabetes mellitus at discharge
Hypoglycemic medication prescribed at discharge for ICH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for ICH patients
Neurosurgery of ICH include removal of hematoma by craniotomy, aspiration of hematoma by drilling, decompressive craniectomy, ventriculocentesis and drainage, other removal of intracranial hematoma
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for SAH
Patients with SAH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression
Measured: 48 hours within hospitalization
Rate of antihypertensive medicine use for SAH patients with hypertension at discharge
Antihypertension medication prescribed at discharge for SAN patients with history of hypertension disease or hypertension disease documented during the hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycemia medication use for SAH patients with diabetes mellitus at discharge
Hypoglycemic medication prescribed at discharge for SAH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for SAH patients
Neurosurgery of SAH include aneurysm clipping, endovascular embolization of aneurysm, extraventricular shunt
Measured: From date of hospitalization until the date of discharge, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 300,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- Dalian Jiuzhou Century Hospital, Dengzhou Central Hospital, Guangxi Ruikang Hospital, Guangdong Second Provincial General Hospital, Handan Central Hospital, Xunxian People's Hospital, Kaifeng Central Hospital, Laoling People's Hospital, New Area People's Hospital of Luoyang, Chinese Traditional Medicine Hospital of Meishan, Mengjin People's Hospital, Nanyang Central Hospital, Hexigten Banner Mongolian Traditional Chinese Medicine Hospital, Inner Mongolian Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Qingdao University, Renqiu Kangjixintu Hospital, Shenzhen Second People's Hospital, Wuhan No.1 Hospital, Xingtai City Ninth Hospital, Yilong People's Hospital, Yongcheng City Central Hospital, Chongqing Donghua Hospital, The Second Affiliated Hospital of Luohe Medical College
- Responsible party
- Principal investigator, Yongjun Wang, MD, Ministry of Science and Technology of the People´s Republic of China
- Investigators
- Zi-Xiao Li, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775836
- Sponsor's protocol ID
- 2017YFC1310901
- Acronym
- PLATFORM-CVD
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the data dictionary of the study. The data could be applied by the PI's email. Applicant should make an SAP first. The PI will check the SAP and appoint a statistician for the analysis.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Platform for Linking and Assessing To Facilitate Outcomes and Research Methods in CerebroVascular Diseases Using Electronic Health Records (PLATFORM-CVD)
- ClinicalTrials.gov ID
- NCT04775836
- Acronym / sponsor ID
- PLATFORM-CVD / 2017YFC1310901
- Conditions
- Stroke, Cerebrovascular Diseases, Cerebral Infarction, Cerebral Hemorrhage, Transient Ischemic Attack, Subarachnoid Hemorrhage
- Keywords
- Healthcare Quality, Electronic Health Records, Cerebrovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300,000 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- Dalian Jiuzhou Century Hospital, Dengzhou Central Hospital, Guangxi Ruikang Hospital, Guangdong Second Provincial General Hospital, Handan Central Hospital, Xunxian People's Hospital, Kaifeng Central Hospital, Laoling People's Hospital, New Area People's Hospital of Luoyang, Chinese Traditional Medicine Hospital of Meishan, Mengjin People's Hospital, Nanyang Central Hospital, Hexigten Banner Mongolian Traditional Chinese Medicine Hospital, Inner Mongolian Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Qingdao University, Renqiu Kangjixintu Hospital, Shenzhen Second People's Hospital, Wuhan No.1 Hospital, Xingtai City Ninth Hospital, Yilong People's Hospital, Yongcheng City Central Hospital, Chongqing Donghua Hospital, The Second Affiliated Hospital of Luohe Medical College
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Mar 2021 (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.
In this protocol, the investigators present methods and preliminary results from the PLATFORM-CVD Study, an EHR-based multicenter cohort. This study will focus on assessing the distribution of major cerebrovascular diseases, determining the risk factors associated with disease incidence and worse in-hospital outcomes, as well as describing the quality of care. Data from this cohort will be used to develop suitable prediction models for cerebrovascular diseases using real-world data and to understand how outcomes for cerebrovascular diseases would change with quality improvement interventions.
Detailed description
Adherence to healthcare quality measures is needed to reduce the burden of cerebrovascular disease and improve clinical outcomes. Electronic health records (EHRs) can facilitate the standardization of care provision and the improvement of disease prediction and prevention. Although the EHRs in clinical settings are increasingly prevalent in China, they are rarely used for healthcare research. the investigators aimed to conduct an EHR-based registry study to improve the healthcare and outcomes for cerebrovascular diseases.
Twenty-four hospitals were enrolled in the PLATFORM-CVD Study in January 2018. Data collection began on February 1st, 2019. Historical data from January 2017 are abstracted first and prospective data are continuously reported until May 20th, 2020. Data were abstracted from the medical records, including hospital information system, laboratory information management system, and picture archiving and communication systems by an extract-transform-load tool. The EHR system included diagnostic information for cerebral infarctions (I63), nontraumatic intracerebral hemorrhages (I61), nontraumatic subarachnoid hemorrhages (I60), transient cerebral ischemic attacks and related syndromes (G45), intracranial and intraspinal phlebitis and thrombophlebitis (G08), vascular dementia (F01), and other aneurysms (I72). The quality of stroke care was assessed by 21 evidence-based performance measures. In-hospital outcomes were calculated including mortality, length of stay, and costs.
The PLATFORM-CVD Study leverages EHRs to better understand incident cerebrovascular diseases in China. Data from this cohort will serve as a unique platform for quality assessment and improvement for acute treatment and secondary prevention of cerebrovascular diseases, as well as in-hospital outcome risk predictions and health economic evaluations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty-five hospitals were enrolled in the PLATFORM-CVD Study between January 1st, 2017 and May 20th, 2020. Hospitals were included if they: 1) had neurological wards; 2) were secondary or tertiary hospitals; 3) could admit at least 20 cerebrovascular disease patients every month.
Key inclusion criteria (8 listed)
- Patients were included in the registry if they were hospitalized with a primary diagnose of：
- cerebral infarction (I63)
- nontraumatic intracerebral hemorrhage (I61)
- nontraumatic subarachnoid hemorrhage (I60)
- transient cerebral ischemic attack and related syndromes (G45)
Key exclusion criteria (1 listed)
- Patients diagnosed with other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Patients who died during hospitalization due to cerebrovascular diseases
Length of stay at hospital
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
The total days for a patients with cerebrovascular diseases at hospitalization
Costs
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
The total costs for a patients with cerebrovascular diseases at hospitalization
21 secondary outcomes
Rate of antiplatelet medication use
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of dual antiplatelet medication use for non-disabling IS and TIA events
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours
Time frame: 48 hours within hospitalization
Cerebrovascular assessment ≤ seven days
Time frame: 7 days within hospitalization
Statin therapy for LDL ≥100 mg/dL during hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication use for atrial fibrillation during hospitalization
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antithrombotic medication prescribtion at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antihypertensive medication prescribtion for patients with hypertension at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of statin prescribtion for low-density lipoprotein≥100 mg/dL at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycaemia medication prescribtion for diabetes mellitus at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication prescribtion for atrial fibrillation at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombolytic therapy
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombectomy therapy
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for ICH
Time frame: 48 hours within hospitalization
Rate of antihypertensive medicine use for ICH patients with hypertension at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycemia medication use for ICH patients with diabetes mellitus at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for ICH patients
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for SAH
Time frame: 48 hours within hospitalization
Rate of antihypertensive medicine use for SAH patients with hypertension at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycemia medication use for SAH patients with diabetes mellitus at discharge
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for SAH patients
Time frame: From date of hospitalization until the date of discharge, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: Yes. We will share the data dictionary of the study. The data could be applied by the PI's email. Applicant should make an SAP first. The PI will check the SAP and appoint a statistician for the analysis.
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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.
Zi-Xiao Li, PhD principal investigator
Beijing Tiantan 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 Stroke and Cerebrovascular Diseases, run by Ministry of Science and Technology of the People´s Republic of China 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 8 inclusion and 1 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 1 Mar 2021. 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 Meng Wang, PhD (13261053863, wangmengpumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: From date of hospitalization until the date of discharge, assessed up to 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2021.