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NCT05472207 Clinical Trial

"Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"

Healthy Clinical Trial

— riskINN  

Official title:
"Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease" ("riskINN ")

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05472207
Other study ID # 1328/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 2030

Study information
Verified date October 2023
Source Medical University Innsbruck
Contact Axel Bauer, Univ.-Prof. Dr.
Phone +43 512 504 25621
Email axel.bauer@i-med.ac.at
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to develop risk prediction models for the early detection of high-risk patients with structural, rhythmological or inflammatory cardiovascular diseases.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date January 2030
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Decision-eligible male and female patients =18 years of age - Acute or chronic condition due to structural, rhythmologic, or inflammatory cardiovascular disease - Informed consent for participation in the clinical trial Exclusion Criteria: - missing infromed consent - pregnant or breast-feeding women

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie Innsbruck Tyrol
Austria Reha Zentrum Münster Münster Tyrol

Sponsors (1)
Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure from inclusion to end of study (max. 4 years)
Secondary total mortality from inclusion to end of study (max. 4 years)
Secondary cardiovascular mortality from inclusion to end of study (max. 4 years)
Secondary stroke from inclusion to end of study (max. 4 years)
Secondary myocardial infarction from inclusion to end of study (max. 4 years)
Secondary hospitalization due to decompensated heart failure from inclusion to end of study (max. 4 years)
Secondary hospitalization due to cardiovascular condition from inclusion to end of study (max. 4 years)
Secondary admission to intensive care unit from inclusion to end of study (max. 4 years)
Secondary severe arrythmic events from inclusion to end of study (max. 4 years)
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