Chronic and Acute Cardiovascular Diseases in Elderly Intensive Care Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age80+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities, frailty, polypharmacy, and functional and cognitive impairment. This prospective multicenter observational study aims to assess the impact of chronic and acute cardiovascular diseases on long-term outcomes and functional trajectories in older ICU patients. Using the international VIP research network, approximately 4,000 patients will be enrolled across different ICU specialties and healthcare systems and assessed multidimensionally using validated clinical scores. The study seeks to improve risk stratification and outcome prediction in older critically ill patients with cardiovascular disease and to address existing evidence gaps in acute cardiovascular and intensive care medicine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
80 years or older
Admission to the intensive care unit
Signed informed consent or absence of discernible indications suggesting the presumed intention of the patient not to participate in the study.
Disqualifiers
< 80 years
Absence of informed consent
Discernible indications suggesting the presumed intention of the patient not to participate in the study.
Trial population
The study focuses on older intensive care unit patients with chronic and acute cardiovascular diseases and is coordinated across multiple international sites using standardized data collection procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
mortality
surivival or death
Time frame
within 6 monthsSecondary outcomes
1
Functionality and Quality of Life
measured by clinical fraility scale: Scores range from 1 (Very Fit) to 9 (Terminally Ill). Higher scores indicate greater frailty and worse health status
Time frame
6 months2
Functionality and Quality of Life
measured by katz acitivies of daily living (assessment of ability to perform daily activities): Scores range from 0 to 6, with higher scores indicating greater independence and better functional status
Time frame
6 months3
Functionality and Quality of Life
measured by EQ-5D-5L (assessment of health-related quality of life): Individual response patterns will be reported as EQ-5D-5L health states (e.g., 11111 indicating no problems in all five dimensions), allowing a descriptive assessment of dimension-specific limitations
Time frame
6 months4
Long-term survival and readmission rate
Long-term survival and readmission rate
Time frame
up to 12 monthsOther outcomes
1
The combined endpoint aims to evaluate both survival outcomes and functional independence
Survival, Improvement or stability in frailty status according to the Clinical Frailty Scale compared to baseline, Improvement or stability in the ability to perform daily activities according to the Katz Activities of Daily Living compared to baseline, Improvement or stability in health-related quality of life according to the EQ-5D-5L compared to baseline.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: