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Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327479
Recruitment Status : Recruiting
First Posted : March 31, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Essen

Brief 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. 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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Cardiovascular Risk Factor SARS Diagnostic Test: Assessment of cardiovascular diseases and cardiovascular risk factors

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 728 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
Actual Study Start Date : March 26, 2020
Estimated Primary Completion Date : March 25, 2026
Estimated Study Completion Date : March 25, 2026

Intervention Details:
  • Diagnostic Test: Assessment of cardiovascular diseases and cardiovascular risk factors
    At inclusion, patients will be screened for pre-existing cardiovascular diseases and cardiovascular risk factors, as well as medication.


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: During 1 year follow-up ]
    mortality of any cause


Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: Within 30 days after inclusion ]
    mortality of any cause

  2. Major adverse cardiovascular events [ Time Frame: During 1 year follow-up ]
    Myocardial infarction, stroke, or CV death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The registry will include consecutive patients, tested for suspected SARS-CoV2/Covid-19 infection at the University Hospital Essen
Criteria

Inclusion Criteria:

  • Patients with suspected SARS-CoV2/Covid-19 infection

Exclusion Criteria:

  • Unwillingness to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327479


Contacts
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Contact: Matthias Totzeck, MD +49201723 ext 84805 matthias.totzeck@uk-essen.de
Contact: Amir A Mahabadi, MD +49201723 ext 84822 amir-abbas.mahabadi@uk-essen.de

Locations
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Germany
University Hospital Essen Recruiting
Essen, NRW, Germany, 45147
Contact: Amir A Mahabadi, MD    +49201723 ext 84822    amir-abbas.mahabadi@uk-essen.de   
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Tienush Rassaf, MD University Hospital Essen, Deparment of Cardiology and Vascular Medicine
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Responsible Party: University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04327479    
Other Study ID Numbers: 20-9213-BO
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will be made available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases