Cardiology Research Dubrava Prospective Registry (CaRDr)

March 15, 2024 updated by: Ivan Zeljkovic, University Hospital Dubrava

Cardiology Research Dubrava: Single Centre, Prospective Registry

Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.

In this long-term follow-up registry we plan to collect data on clinical status, standard laboratory results including lipidogram values, NTproBNP values after specific interventions (in.ex. TAVI implantation, SGLT2inh prescripition), bleeding complications, and every major cardiovascular event, including cardiovascular death and all cause death.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ivan Zeljkovic, M.D.
  • Phone Number: 00385917823289
  • Email: kardio@kbd.hr

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Dubrava University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with different cardiology pathology and diseases including arrhythmias, heart failure, venousn thromboembolism, implanted with CIED

Description

Inclusion Criteria: patients implanted with CIED, or with VTE, or with ACS or with TAVI -

Exclusion Criteria: non compliance, not undergoing follow-up at this center

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute coronary syndrome - ACS
patients who were diagnosed with acute coronary syndrome: STEMI, non-STE ACS - NSTEMI and unstable angina, who underwent coronary angiography and were prescribed with optimal medicament therapy
Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,
long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital
Transcatheter aortic valve implantation - TAVI
patients with aortic stenosis who underwent transcatheter percotaneous implantation of the arteficial aortic valve
Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,
long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital
Venous thromboembolism - VTE
patients with pulmonary embolism and deep vein thrombosis, with a focus on those who underwent thromboaspiration due to high or medium-high risk pulmonary embolism
Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,
long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital
Heart failure with SGLT2 inhibitor therapy included - HF-SGLT2
patients with heart failure with reduced, mid-reduced and preserved systolic function who were prescribed with a SGLT-2 inhibitor therapy, and other optimal medicament therapy for HF
Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,
long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital
Cardiac implantable electronic device - CIED
patients who were implanted with a cardiac implantable electronic device: pacemaker, conduction system pacing device, cardioverter-defibrilator or cardiac resynchronization therapy with or without defibrilator option
Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,
long-term follow up and observation of patients treated in Cardiology department in the tertiary center and University hospital
Arrhythmias
patients who underwent electrophysiology study, including PVI for atrial fibrillation, as well as SVT ablations, and ventricular arrhythmia ablation (both premature ventriclar beats and ventricular tachycardia ablation in ischsmic and non-ischemic cardiomyopathy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiovascular death
Time Frame: 10 years
death due to cardiovascular etiology during long term follow-up
10 years
freedom from atrial arrhythmias
Time Frame: 10 years
Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up
10 years
Time to revascularization
Time Frame: 10 years
Time to revascularization during acute coronary syndrome
10 years
Bleeding complications
Time Frame: 10 years
Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy
10 years
Laboratory levels of NTproBNP
Time Frame: 10 years
Laboratory levels of NTproBNP in patients with AFib after PVI, in patients with HF prescribed with SGLT2 inhibitors, in patients with ACS after complete revasculariazation, in patients implanted with CIED
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Dubrava

Investigators

  • Study Chair: Ivana Jurin, M.D., Dubrava University Hospital
  • Principal Investigator: Irzal Hadzibegovic, M.D., Dubrava University Hospital
  • Principal Investigator: Nikola Pavlovic, M.D., Dubrava University Hospital
  • Principal Investigator: Marin Pavlov, M.D., Dubrava University Hospital
  • Principal Investigator: Mario Udovicic, M.D., Dubrava University Hospital
  • Principal Investigator: Danijel Unic, M.D., Dubrava University Hospital
  • Principal Investigator: Ana Jordan, M.D., Dubrava University Hospital
  • Principal Investigator: Tomislav Sipic, M.D., Dubrava University Hospital
  • Principal Investigator: Diana Rudan, M.D., Dubrava University Hospital
  • Study Director: Sime Manola, M.D., Dubrava University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2033

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DUH-012017

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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