"Multifactorial Risk Stratification in Acute and Chronic... | NCT05472207

Studies
"Multifactorial Risk Stratification in Acute and Chronic Cardiovascular Disease"

NCT05472207

Sponsor

Medical University Innsbruck

Status

Recruiting

Last Update Posted

Nov 21, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cardiovascular Diseases
Healthy

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Jan 2030Estimated

First Submitted Date

Jul 21, 2022

First Submission Date that Met QC Criteria

Jul 21, 2022

First Posted Date

Jul 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2024

Last Update Posted Date

Nov 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Univ. Prof. Dr. Axel Bauer, Univ.-Prof. Dr., Medical University InnsbruckPrincipal Investigator

Lead Sponsor

Medical University InnsbruckOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with cardiovascular diseases		Recording clinical data - especially risk parameters - from patients suffering from cardiovascular diseases

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Individuals suffering from an acute or chronic cardiovascular disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Axel Bauer, Univ.-Prof. Dr.	Contact	+43 512 504 25621		axel.bauer@i-med.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III, Kardiologie & Angiologie	Recruiting	Innsbruck	Tyrol	6020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided