Berlin Longterm Observation of Vascular Events

Recruiting

• Conditions: I21; I61; I63; N17; H34.1; G45.0; G45.1; G45.2; G45.3; G45.9

• Registration Number: DRKS00023323
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Results First Posted: 2023-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

1)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)recent diagnosis of one or more of the following diseases:
a) acute heart failure (trigger event)
b) acute coronary syndrome (trigger event)
c) acute cerebrovascular disorders (trigger event)
d) acute kidney injury (trigger event)
6) eligibility for the reference group, that is presence of a chronic vascular high-risk condition according to ESC-guidelines for lipid disorders 2020 and cardiovascular disease prevention 2021

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
6. patients with active malignant cancer disease, that are currently in medical treatment OR for whom there is a medical indication for treatment OR who have been treated for the disease less than 6 month ago OR that experience complications of the disease including side effects of treatment
7. Stroke arm: patients with a symptom duration > 24hrs who had an MRI in the acute phase, that did neither show fresh infarction (based on DWI-criteria) nor fresh hemorrhage shall not be included
8. Acute heart failure arm: AHF in the context of a hospitalization for acute coronary syndrome, acute stroke, or acute kidney injury
9. Chronic high-risk arm a history of an acute trigger event as defined by the inclusion criteria within the last 12 months

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
composite endpoint consisting of major adverse events (MACE) that occut for the first time since study inclusion: cardiovascular mortality, non-lethal stroke, non-fatal myocardial infarction and rehospitalization due to cardiac insufficiency<br><br>

Secondary Outcome Measures

Name	Time	Method
1. All cause mortality<br>2. MACE<br>• recurrent/secondary MACE events<br>• burden of all MACE events per pt<br><br>3. Cardiovascular events<br>• hospitalization for unstable angina pectoris<br>• coronary revascularization<br><br>4. Cerebrovascular events<br>• TIA<br>• Subarachnoid hemorrhage (SAH)<br>• Carotid artery stenting or TEA<br>• PFO closure<br>• clipping or resection of a intracranial aneurysm<br><br>5. Peripheral vascular events<br>• amputation due to PAD<br>• revascularization of peripheral arteries<br>• pulmonary artery embolism<br>• diabetic end-organ damage (micronagiopathy)<br><br>6. Major adverse kidney event, MAKE<br>7. Every acute kidney injury<br>