Cardiology Research Dubrava Prospective Registry (CaRDr)

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: Heart Failure; Atrial Fibrillation; Arrhythmias, Cardiac; Acute Coronary Syndrome
• Intervention / Treatment: Other: SGLT-2 inh therapy, CIED implantation, thromboaspiration,

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

• Study Contact: Name: Ivana Jurin, M.D.; Email: ivanajurin1912@gmail.com
• 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: Sime Manola, M.D.; Email: kardio@kbd.hr

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

6

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	death due to cardiovascular etiology during long term follow-up	10 years
freedom from atrial arrhythmias	Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up	10 years
Time to revascularization	Time to revascularization during acute coronary syndrome	10 years
Bleeding complications	Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy	10 years
Laboratory levels of NTproBNP	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

• 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

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: atrial fibrillation; acute coronary syndrome; anticoagulants; NTproBNP; chronic heart failure; SGLT-2 inhibitors; cardiac implanted electronic device; observationl
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Atrial Fibrillation; Arrhythmias, Cardiac; Acute Coronary Syndrome
• 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