Cardiovascular DiseasesNCT04327479
Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factor, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infects host-cells via ACE2-receptors, which leads to pneumonia (COVID-19) but also can lead to myocarditis (acute myocardial injury) and chronic damage to the cardiovascular system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, SARS
- What is being tested?
- Assessment of cardiovascular diseases and cardiovascular risk factors
- How many people
- 728 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2020to 25 Jul 2022
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry will include consecutive patients, tested for suspected SARS-CoV2/Covid-19 infection at the University Hospital Essen
Who may be able to join
- Patients with suspected SARS-CoV2/Covid-19 infection
Who cannot join
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infects host-cells via ACE2-receptors, which leads to pneumonia (COVID-19) but also can lead to myocarditis (acute myocardial injury) and chronic damage to the cardiovascular system. Therefore, cardiovascular protection may be necessary when treating patients with COVID-19 infection. This may especially be necessary in patients with cardiovascular diseases, risk factors, and co-medication.
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, SARS
- Being tested
- Assessment of cardiovascular diseases and cardiovascular risk factors
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of cardiovascular diseases and cardiovascular risk factorsDiagnostic test
At inclusion, patients will be screened for pre-existing cardiovascular diseases and cardiovascular risk factors, as well as medication.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
mortality of any cause
Measured: During 1 year follow-up
Secondary outcomes (2)
30-day mortality
mortality of any cause
Measured: Within 30 days after inclusion
Major adverse cardiovascular events
Myocardial infarction, stroke, or CV death
Measured: During 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start26 Mar 2020
- Primary completion25 Mar 2022
- Study completion25 Jul 2022
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 Cardiovascular DiseasesStudies 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
- 728 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tienush Rassaf, MD, Principal investigator, University Hospital Essen, Deparment of Cardiology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327479
- Sponsor's protocol ID
- 20-9213-BO
- Status last verified
- Nov 2022
- First submitted
- 26 Mar 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be made available upon request
Publications
Mahabadi AA, Mincu R, Dykun I, Michel L, Kung A, Witzke O, Kill C, Buer J, Rassaf T, Totzeck M. Frequency and prognosis of CVD and myocardial injury in patients presenting with suspected COVID-19 - The CoV-COR registry. Int J Cardiol Heart Vasc. 2023 Apr;45:101184. doi: 10.1016/j.ijcha.2023.101184. Epub 2023 Feb 6.
PubMed 36776683
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04327479
- Acronym / sponsor ID
- 20-9213-BO
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, SARS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 26 Mar 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 31 Mar 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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infects host-cells via ACE2-receptors, which leads to pneumonia (COVID-19) but also can lead to myocarditis (acute myocardial injury) and chronic damage to the cardiovascular system. Therefore, cardiovascular protection may be necessary when treating patients with COVID-19 infection. This may especially be necessary in patients with cardiovascular diseases, risk factors, and co-medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will include consecutive patients, tested for suspected SARS-CoV2/Covid-19 infection at the University Hospital Essen
Key inclusion criteria (1 listed)
- Patients with suspected SARS-CoV2/Covid-19 infection
Key exclusion criteria (1 listed)
- Unwillingness to participate
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 |
|---|---|---|
| Assessment of cardiovascular diseases and cardiovascular risk factorsAt inclusion, patients will be screened for pre-existing cardiovascular diseases and cardiovascular risk factors, as well as medication. | Diagnostic test | – |
Primary outcome
All-cause mortality
Time frame: During 1 year follow-up
mortality of any cause
2 secondary outcomes
30-day mortality
Time frame: Within 30 days after inclusion
Major adverse cardiovascular events
Time frame: During 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 36776683Mahabadi AA, Mincu R, Dykun I, Michel L, Kung A, Witzke O, Kill C, Buer J, Rassaf T, Totzeck M. Frequency and prognosis of CVD and myocardial injury in patients presenting with suspected COVID-19 - The CoV-COR registry. Int J Cardiol Heart Vasc. 2023 Apr;45:101184. doi: 10.1016/j.ijcha.2023.101184. Epub 2023 Feb 6.
- Individual participant dataSharing planned: No. Will be made available upon request
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Tienush Rassaf, MD principal investigator
University Hospital Essen, Deparment of Cardiology and Vascular Medicine
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 Cardiovascular Diseases and Cardiovascular Risk Factor, run by University Hospital, Essen at 1 site in Germany.
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: finished, as of the sponsor's last update on 3 Nov 2022. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: During 1 year follow-up). 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 NCT04327479, 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 3 Nov 2022.