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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327479
Recruitment Status : Completed
First Posted : March 31, 2020
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Essen

Tracking Information
First Submitted Date March 26, 2020
First Posted Date March 31, 2020
Last Update Posted Date November 3, 2022
Actual Study Start Date March 26, 2020
Actual Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2020)		 All-cause mortality [ Time Frame: During 1 year follow-up ]
mortality of any cause
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2020)
  • 30-day mortality [ Time Frame: Within 30 days after inclusion ]
    mortality of any cause
  • Major adverse cardiovascular events [ Time Frame: During 1 year follow-up ]
    Myocardial infarction, stroke, or CV death
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
Official Title Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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
Condition
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • SARS
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2020)		 728
Original Estimated Enrollment
 (submitted: March 26, 2020)		 6000
Actual Study Completion Date July 25, 2022
Actual Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unwillingness to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04327479
Other Study ID Numbers 20-9213-BO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Will be made available upon request
Current Responsible Party University Hospital, Essen
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Essen
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Tienush Rassaf, MD University Hospital Essen, Deparment of Cardiology and Vascular Medicine
PRS Account University Hospital, Essen
Verification Date November 2022