NCT05472207

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2021Jan 2030

Study Start

First participant enrolled

January 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

5 years

First QC Date

July 21, 2022

Last Update Submit

November 19, 2024

Conditions

Cardiovascular DiseasesHealthy

Outcome Measures

Primary Outcomes (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 Outcomes (8)

  • 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)

  • +3 more secondary outcomes

Study Arms (1)

Patients with cardiovascular diseases

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals suffering from an acute or chronic cardiovascular disease

You may qualify if:

  • 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

You may not qualify if:

  • missing infromed consent
  • pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Reha Zentrum Münster

Münster, Tyrol, 6232, Austria

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Axel Bauer, Univ.-Prof. Dr.

CONTACT

+43 512 504 25621axel.bauer@i-med.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr.

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2030

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)