NL-OMON52303RecruitingNot Applicable
A prospective cohort study evaluating the occurrence of short and long-term cardiovascular complications in patients hospitalized with COVID-19 - CAPACITY 2
niversitair Medisch Centrum Utrecht0 sites500 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Age >=18 and <70 years
- •A PCR confirmed infection with SARS-CoV-2 <48h of admission
- •Treatment of COVID-19 is the primary reason of hospitalization
- •The patient was independent in ADL prior to admission
- •The patient or proxy (close relative) is capable of giving informed consent
- •To be included in the healthcare pathway group, at least two of the following
- •additional criteria should be met within 48h of admission:
- •Troponin levels >4x ULN
- •New ECG abnormalities including repolarization abnormalities, arrhythmia,
- •signs of right ventricular strain, axis deviation, dynamic ECG changes or any
- •other new abnormalities on ECG deemed clinically relevant by a cardiologist.
- •NOTE: This criterion is not met in case of any (likely) pre-existent
- •electrocardiographic abnormalities.
- •Suspicion of cardiac disease
- •To be included in the control group, at least two of the following criteria
- •should be met within 48h of admission:
- •Troponin levels <4x ULN
- •No new ECG abnormalities including repolarization abnormalities, arrhythmia,
- •signs of right ventricular strain, axis deviation, dynamic ECG changes or any
- •other abnormalities deemed clinically relevant by a cardiologist).
- •No suspicion of cardiac disease
Exclusion Criteria
- •Anticipated) in-hospital stay <48h
- •First admission for COVID-19 took place in another hospital and the patient
- •was transferred to the current hospital >48h after first admission
- •Recent (<6 months) cardiac pathology prior to hospital admission including:
- •o Myocardial infarction or unstable angina
- •o Decompensated heart failure that required hospital admission
- •o Uncontrolled ventricular arrhythmia
- •o Percutaneous coronary intervention, CABG, valvular replacement or any other
- •major cardiac surgery
- •o Cardiac device implantation
- •o NOTE: Cardiac pathology secondary to a SARS-CoV-2 infection is not a reason
- •for exclusion.
- •Anatomical deviations (incl. breast implants) anticipated to significantly
- •hamper the echocardiographic imaging quality
- •Clinical signs of severe cerebral dysfunction
- •Any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol
- •(Planned) pregnancy
Investigators
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