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riskINN: "Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"

Sponsor
Medical University Innsbruck (Other)
Overall Status
Recruiting
CT.gov ID
NCT05472207
Collaborator
(none)
5,000
Enrollment
2
Locations
108
Anticipated Duration (Months)
2500
Patients Per Site
23.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    "Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease" ("riskINN ")
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jan 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with cardiovascular diseases

    Recording clinical data - especially risk parameters - from patients suffering from cardiovascular diseases

    Outcome Measures

    Primary Outcome Measures

    1. combination of cardiovascular mortality, stroke, myocardial infarction and hospitalization due to decompensated heart failure [from inclusion to end of study (max. 4 years)]

    Secondary Outcome Measures

    1. total mortality [from inclusion to end of study (max. 4 years)]

    2. cardiovascular mortality [from inclusion to end of study (max. 4 years)]

    3. stroke [from inclusion to end of study (max. 4 years)]

    4. myocardial infarction [from inclusion to end of study (max. 4 years)]

    5. hospitalization due to decompensated heart failure [from inclusion to end of study (max. 4 years)]

    6. hospitalization due to cardiovascular condition [from inclusion to end of study (max. 4 years)]

    7. admission to intensive care unit [from inclusion to end of study (max. 4 years)]

    8. severe arrythmic events [from inclusion to end of study (max. 4 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie Innsbruck Tyrol Austria 6020
    2 Reha Zentrum Münster Münster Tyrol Austria 6232

    Sponsors and Collaborators

    • Medical University Innsbruck

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Univ. Prof. Dr. Axel Bauer, Univ.-Prof. Dr., Medical University Innsbruck
    ClinicalTrials.gov Identifier:
    NCT05472207
    Other Study ID Numbers:
    • 1328/2020
    First Posted:
    Jul 25, 2022
    Last Update Posted:
    Jul 25, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Jul 25, 2022