NCT04327479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
728

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

March 26, 2020

Last Update Submit

November 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    mortality of any cause

    During 1 year follow-up

Secondary Outcomes (2)

  • 30-day mortality

    Within 30 days after inclusion

  • Major adverse cardiovascular events

    During 1 year follow-up

Interventions

At inclusion, patients will be screened for pre-existing cardiovascular diseases and cardiovascular risk factors, as well as medication.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The registry will include consecutive patients, tested for suspected SARS-CoV2/Covid-19 infection at the University Hospital Essen

You may qualify if:

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

You may not qualify if:

  • Unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Tienush Rassaf, MD

    University Hospital Essen, Deparment of Cardiology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 31, 2020

Study Start

March 26, 2020

Primary Completion

March 25, 2022

Study Completion

July 25, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Will be made available upon request

Locations