Berlin Longterm Observation of Vascular Events - Pilot study

• Conditions: Intracerebral haemorrhage; I21; I61; I63; E11; N17; I67.6; H34.1; H47.0; G45.0

• Registration Number: DRKS00016852
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2248

Inclusion Criteria

provision of signed and dated informed consent form
2)declared willingness to take part in study procedures and to be contacted again for further
follow-up examinations
3)persons of any sex and gender, aged 18 years or above at the time of acute event or study
inclusion
4)general health status is acceptable for participation in a study
5)clinical diagnosis of one or more of the following diseases:
A) acute heart failure (trigger event), defined by:
i) dyspnoe NYHA IIIb or IV and NTproBNP = 300 pg/nl OR
MRproANP = 120 pmol/l, AND

ii)evidence of pitting peripheral edema or radiological or clinical signs of
of pulmonary congestion, AND
iii)Need for i.v.-administration or dose escalation of diuretic therapie
equivalent to furosemid 40 mg or torasemid of 10 mg.

B) acute coronary syndrome (trigger event), defined by:
i) acute cardiac chest pain, or angina equivalent consistent with moderate to high-
risk unstable angina or myocardial infarction, lasting more than 10 minutes
duration during72 hours before invasive examination, AND
ii) evidence for ACS requiring catheterization documented by
(1)elevated enzymes (CK-MB or hs-troponin i/T >99th percentile or in-
/decrease) AND/OR
(2)ECG with ST-depression >1mm in 2 or more contiguous leads after the
J-point AND/OR
(3)transient ST-elevation >1mm in 2 or more contiguous leads lasting
<30 min OR
(4)STE-ACS with onset <24 hours previously and chest pain > 30 min
ST-elevation > 1mm in 2 or more contiguous leads or new left bundle block

C) acute cerebrovascular disorders (trigger event), defined by:
i) a transient ischemic attack (TIA) with clinical restitution within 24h AND
initial neurological deficit verified by a neurologist OR ABCD2-Score >= 3 OR
visibleDWI-lesion (MRI) OR the main hospital diagnosis of Amaurosis fugax
ii) Ischemic stroke including retinal central artery occlusion
iii) stroke caused by non-traumatic intracerebral hemorrhage
iv) stroke caused by cerebral venous thrombosis

D) acute kidney injury while hospitalized, that occurred 3-8 days before study inclusion
(trigger event), defined by:
i) >= 2fold increase in creatinine compared to a respective value during a presumed
or documented time period (stage 2 or 3 acute kidney injury according to KDIGO)
ii) persistence of the increased value for at least 72 hrs

E) diabetes mellitus type 2 (at day 60)
i) known diabetes mellitus type 2 characterized by
(1) pathological findings in oral glucose tolerance test, OR
(2) documented HbA1c >= 6.5%, OR
(3) Intake of any antidiabetic medication
ii) prediabetes with high cardiovascular risk, characterized by
(1)HbA1c >5.7% and <6.5% AND an ESC score >= 5

Exclusion Criteria

1) lack of capacity to give informed consent
2) pregnancy or lactation
3) life expectancy < 6 months due to non-cardio-/cerebrovascular diseases or conditions
4) organ transplanted
5) Lack of health insurance

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint consisting of: cardiovascular mortality, non-fatal stroke, non-fatal myoracial infarction, rehospitalization due to heart failure