CaRDr: Cardiology Research Dubrava Prospective Registry

Sponsor
University Hospital Dubrava (Other)
Overall Status
Recruiting
CT.gov ID
NCT06090591
Collaborator
(none)
3,000
1
125
24

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiology Research Dubrava: Single Centre, Prospective Registry
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2033
Anticipated Study Completion Date :
Jun 1, 2033

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. cardiovascular death [10 years]

    death due to cardiovascular etiology during long term follow-up

  2. freedom from atrial arrhythmias [10 years]

    Freedom from atrial arrhythmias after PVI during mid-term folow-up (1 year) and long-term follow-up

  3. Time to revascularization [10 years]

    Time to revascularization during acute coronary syndrome

  4. Bleeding complications [10 years]

    Bleeding complications during long-term follow-up in patients prescribed with oral anticoagulation and/or antithrombotic therapy

  5. Laboratory levels of NTproBNP [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dubrava University Hospital Zagreb Croatia 10000

Sponsors and Collaborators

  • University Hospital Dubrava

Investigators

  • Study Chair: Ivana Jurin, M.D., Dubrava University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ivan Zeljkovic, M.D., Ph.D., Associate Professor, University Hospital Dubrava
ClinicalTrials.gov Identifier:
NCT06090591
Other Study ID Numbers:
  • DUH-012017
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 26, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ivan Zeljkovic, M.D., Ph.D., Associate Professor, University Hospital Dubrava
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2023