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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Healthy

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Axel Bauer, Univ.-Prof. Dr.; Phone Number: +43 512 504 25621; Email: axel.bauer@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie
      • Contact: Axel Bauer, Univ.Prof. Dr.; Phone Number: +43 512 504 25621; Email: axel.bauer@i-med.ac.at
      • Contact: Theresa Dolejsi, Dr.
      • Contact: Michael Schreinlechner, Dr.
      • Contact: Michael Toifl, DI
      • Contact: Nikolay Sappler, Dr.
      • Contact: Fabian Theurl, Dr.
    • Münster, Tyrol, Austria, 6232
      • Recruiting
      • Reha Zentrum Münster
      • Contact: Rudolf Kirchmair, Ao. Univ.Prof.Dr.; Phone Number: +43533720004
      • Contact: Theresa Dolejsi, Dr.
      • Contact: Michael Schreinlechner, Dr.
      • Contact: Nikolay Sappler, Dr.
      • Contact: Fabian Theurl, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Individuals suffering from an acute or chronic cardiovascular disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with cardiovascular diseases; Recording clinical data - especially risk parameters - from patients suffering from cardiovascular diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
total mortality	from inclusion to end of study (max. 4 years)
cardiovascular mortality	from inclusion to end of study (max. 4 years)
stroke	from inclusion to end of study (max. 4 years)
myocardial infarction	from inclusion to end of study (max. 4 years)
hospitalization due to decompensated heart failure	from inclusion to end of study (max. 4 years)
hospitalization due to cardiovascular condition	from inclusion to end of study (max. 4 years)
admission to intensive care unit	from inclusion to end of study (max. 4 years)
severe arrythmic events	from inclusion to end of study (max. 4 years)

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 1328/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No