STEMINCT04427735
Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI
An observational study of STEMI, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2019to 24 Jul 2021
- 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 with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention
Who may be able to join
- Continuous inclusion of patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention.
Who cannot join
- Febrile patients, patients with severe infection,
- ST segment elevation myocardial infarction during hospitalization,
- Patients who could not cooperate with each other.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Hongwei Li, 0086 10 63139780, lhw19656@sina.com
Xuhe Gong, 0086 10 63139780, gongxuhe123@126.com
About this study
Official title: Effect of Covid-19 Epidemic on Primary PCI and Prognosis in Patients With Acute STEMI
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment.
Read the detailed description
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. The patients' prognosis is poor because the epidemic situation runs on medical resources, delays the diagnosis and treatment of other diseases such as cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more damage to the patients. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic. In this study, STEMI patients who experienced emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular opening time,and the major cardiovascular adverse events, which provide effective suggestions and strategies for emergency and severe treatment.
- Conditions
- STEMI
- Keywords
- covid-19, STEMI, primary PCI
- Medical subject headings
- ST Elevation Myocardial Infarction, COVID-19
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 |
|---|---|---|
| before COVID-19 | Patients with myocardial infarction from January 24, 2019 to June 24, 2019 | |
| after COVID-19 | Patients with myocardial infarction from January 24, 2020 to June 24, 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (major adverse cardiovascular events)
cardiovascular death, re-infarction, malignant arrhythmia,heart failure, revascularization, and stroke
Measured: 1 year
all-cause death
death caused by all reason
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start24 Jan 2019
- Primary completion24 Jul 2021 (estimated)
- Study completion24 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 200 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
- Hongwei Li, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427735
- Sponsor's protocol ID
- BFH-COVID-19 and Primary PCI
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gong X, Zhou L, Dong T, Ding X, Zhao H, Chen H, Li H. Impact of COVID-19 pandemic on STEMI undergoing primary PCI treatment in Beijing, China. Am J Emerg Med. 2022 Mar;53:68-72. doi: 10.1016/j.ajem.2021.11.034. Epub 2021 Nov 24.
PubMed 34999563
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Covid-19 Epidemic on Primary PCI and Prognosis in Patients With Acute STEMI
- ClinicalTrials.gov ID
- NCT04427735
- Acronym / sponsor ID
- BFH-COVID-19 and Primary PCI
- Conditions
- STEMI
- Keywords
- covid-19, STEMI, primary PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 24 Jul 2021 (estimated)
- Study completion
- 24 Jul 2021 (estimated)
- First posted
- 11 Jun 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.
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment.
Detailed description
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. The patients' prognosis is poor because the epidemic situation runs on medical resources, delays the diagnosis and treatment of other diseases such as cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more damage to the patients. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic. In this study, STEMI patients who experienced emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular opening time,and the major cardiovascular adverse events, which provide effective suggestions and strategies for emergency and severe treatment.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| before COVID-19 | – | –Patients with myocardial infarction from January 24, 2019 to June 24, 2019 |
| after COVID-19 | – | –Patients with myocardial infarction from January 24, 2020 to June 24, 2020 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention
Key inclusion criteria (1 listed)
- Continuous inclusion of patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention.
Key exclusion criteria (3 listed)
- Febrile patients, patients with severe infection,
- ST segment elevation myocardial infarction during hospitalization,
- Patients who could not cooperate with each other.
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
MACE (major adverse cardiovascular events)
Time frame: 1 year
cardiovascular death, re-infarction, malignant arrhythmia,heart failure, revascularization, and stroke
all-cause death
Time frame: 1 year
death caused by all reason
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 34999563Gong X, Zhou L, Dong T, Ding X, Zhao H, Chen H, Li H. Impact of COVID-19 pandemic on STEMI undergoing primary PCI treatment in Beijing, China. Am J Emerg Med. 2022 Mar;53:68-72. doi: 10.1016/j.ajem.2021.11.034. Epub 2021 Nov 24.
Related trials for STEMI
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
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.
Hongwei Li study chair
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 STEMI, 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 1 inclusion and 3 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 11 Jun 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, doctor (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: 1 year). The study lists 2 primary outcomes in all. 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 NCT04427735, which also lists 1 linked publication.
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 11 Jun 2020.