Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
Sponsor
University Hospital, Essen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04327479
Collaborator
(none)
728
1
72
10.1
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
728 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Characterization of Cardiovascular Diseases and Risk Factors in Patients With Suspected SARS-CoV2/Covid-19 Infection
Actual Study Start Date
:
Mar 26, 2020
Anticipated Primary Completion Date
:
Mar 25, 2026
Anticipated Study Completion Date
:
Mar 25, 2026
Outcome Measures
Primary Outcome Measures
- All-cause mortality [During 1 year follow-up]
mortality of any cause
Secondary Outcome Measures
- 30-day mortality [Within 30 days after inclusion]
mortality of any cause
- Major adverse cardiovascular events [During 1 year follow-up]
Myocardial infarction, stroke, or CV death
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with suspected SARS-CoV2/Covid-19 infection
Exclusion Criteria:
- Unwillingness to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Essen | Essen | NRW | Germany | 45147 |
Sponsors and Collaborators
- University Hospital, Essen
Investigators
- Principal Investigator: Tienush Rassaf, MD, University Hospital Essen, Deparment of Cardiology and Vascular Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT04327479
Other Study ID Numbers:
- 20-9213-BO
First Posted:
Mar 31, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: