NCT06371677

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

April 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 14, 2024

Last Update Submit

April 14, 2024

Conditions

ShockDeathCardiac Intensive Care UnitTreatment ComplicationStrokeMultiple Organ FailureInfections

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    01.10.2024 - 31.03.2025

Secondary Outcomes (2)

  • 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

Eligibility Criteria

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

All consecutive patients hospitalized at Polish CICUs.

All consecutive patients hospitalized at Polish CICUs.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

ShockDeathStrokeMultiple Organ FailureInfections

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

Central Study Contacts

Robert Kowalik, MD, PhD

CONTACT

22 599 19 58rjkowalik@wp.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2024

First Posted

April 17, 2024

Study Start

October 1, 2024

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

April 17, 2024

Record last verified: 2024-04