Polish Nationwide Register of Hospitalized Patients in Ca... | NCT06371677

Studies
Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units

NCT06371677

Sponsor

Medical University of Warsaw

Status

Unknown status

Last Update Posted

Apr 17, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Shock
Death
Cardiac Intensive Care Unit
Treatment Complication
Stroke
Multiple Organ Failure
Infections

Interventions

Not provided

Countries

Not provided

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Mar 31, 2025Estimated

First Submitted Date

Apr 14, 2024

First Submission Date that Met QC Criteria

Apr 14, 2024

First Posted Date

Apr 17, 2024Actual

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

Apr 14, 2024

Last Update Posted Date

Apr 17, 2024Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs.

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

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause death		01.10.2024 - 31.03.2025

Secondary Outcomes

Measure	Description	Time Frame
Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive)		01.10.2024 - 31.03.2025
Treatment-related complications (tamponade, dissection, stroke, embolism, etc.)		01.10.2024 - 31.03.2025

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

All consecutive patients hospitalized at Polish CICUs.

Accepts Healthy Volunteers

Yes

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

All consecutive patients hospitalized at Polish CICUs.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert Kowalik, MD, PhD	Contact	22 599 19 58	+48	rjkowalik@wp.pl

Overall Officials

Name	Affiliation	Role
Robert Kowalik, MD, PhD	1st Department of Cardiology, Medical University of Warsaw	Principal Investigator
Monika Gawałko, MD, PhD	1st Department of Cardiology, Medical University of Warsaw	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012769	Shock
D003643	Death
D020521	Stroke
D009102	Multiple Organ Failure
D007239	Infections

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided