Cardiovascular Death; Major Adverse Cardiovascular EventsNCT04255940
2019-nCoV Outbreak and Cardiovascular Diseases
An observational study of Cardiovascular Death; Major Adverse Cardiovascular Events, run by Qilu Hospital of Shandong University at 12 sites in China.
Trial summary
Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Death; Major Adverse Cardiovascular Events
- How many people
- 12,000 participants
- Where
- 12 sitesChina
- Study dates
- 20 Jan 2020to 30 Apr 2020
- 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: Patients visiting emergency department.
Who may be able to join
- Patients visiting emergency department.
Who cannot join
- -
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Affiliated Hospital of Binzhou Medical Universty
Binzhou, Shandong
Min Feng, MD, PhD
Min Feng, MD, PhD
- Recruiting
Heze Municipal Hospital
Heze, Shandong
Lujing Meng, MD
Lujing Meng, MD
- Recruiting
Shandong University Qilu Hospital
Jinan, Shandong, 250012
Panpan Hao, MD, PHD, panda.how@126.com
Yanping Liu, MD
- Recruiting
Jinan Central Hospital, Shandong University
Jinan, Shandong, 250013
Bin Li, MD, qingquan0615@163.com
Peixin Hu, MD
- Recruiting
First Hospital Affiliated with Shandong First Medical University
Jinan, Shandong, 250014
Zhongwen Zhang, MD, PHD, 18553104425, zhangzhongwen521@126.com
- Recruiting
Shandong Provincial Hospital, Shandong University
Jinan, Shandong, 250021
Xin Zhang, MD
Xin Zhang, MD
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong
kun Wen, MD
Kun Wen, MD
- Recruiting
Jining Hospital of Traditional Chinese Medicine
Jining, Shandong
Zhengyan Qu, MD
Zhengyan Qu, MD
- Recruiting
Qihe People's Hospital
Qihe, Shandong
Jianjun Lu, MD
Jianjun Lu, MD
- Recruiting
Affiliated Hospital of Qingdao University Medical College
Qingdao, Shandong, 266003
Liang Shan, MD
Liang Shan, MD
- Recruiting
Weihai Municipal Hospital
Weihai, Shandong
Lei Cao, MD
Lei Cao, MD
- Recruiting
Central Hospital of Zibo
Zibo, Shandong
Bo Li, MD, PhD
Bo Li, MD, PhD
About this study
Official title: Impact of a Novel Coronavirus (2019-nCoV) Outbreak on Public Anxiety and Cardiovascular Disease Risk in China
Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.
Read the detailed description
This survey aims to assess whether the public anxiety from a novel coronavirus (2019-nCoV) outbreak increases cardiovascular disease risk in China. Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| After outbreak | Not described | |
| Past 3 months | Not described | |
| Last year | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Death
Measured: 3 months
Secondary outcomes (3)
Major Adverse Cardiovascular Events
Measured: 3 months
Times From symptom onset to hospital arrival
Measured: 3 months
Anxiety
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Jan 2020
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Death; Major Adverse Cardiovascular EventsStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan-Pan Hao, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255940
- Sponsor's protocol ID
- 2019nCoV-CVD
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Novel Coronavirus (2019-nCoV) Outbreak on Public Anxiety and Cardiovascular Disease Risk in China
- ClinicalTrials.gov ID
- NCT04255940
- Acronym / sponsor ID
- 2019nCoV-CVD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 5 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.
Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.
Detailed description
This survey aims to assess whether the public anxiety from a novel coronavirus (2019-nCoV) outbreak increases cardiovascular disease risk in China. Cardiovascular events occurring after 2019-nCoV outbreak in Jinan were prospectively assessed by emergency physicians. We compared those events with events that occurred during the past 3 months and the same months of the last year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| After outbreak | – | – |
| Past 3 months | – | – |
| Last year | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients visiting emergency department.
Key inclusion criteria (1 listed)
- Patients visiting emergency department.
Key exclusion criteria (1 listed)
- -
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
Cardiovascular Death
Time frame: 3 months
3 secondary outcomes
Major Adverse Cardiovascular Events
Time frame: 3 months
Times From symptom onset to hospital arrival
Time frame: 3 months
Anxiety
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Death; Major Adverse Cardiovascular Events, run by Qilu Hospital of Shandong University at 12 sites 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 1 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 5 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 12 sites 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 Panpan Hao, MD (86-18560086593, panda.how@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Death (time frame: 3 months). 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 5 Feb 2020.