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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02276950
Other study ID # HARTROCS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2011
Est. completion date December 2025

Study information

Verified date October 2023
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall project aim is to study risk and outcomes following cardiac surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.


Description:

The purpose of this research project is to study risks and outcomes in patients who underwent cardiac surgery. We aim to establish a fundament for the conduct of nationwide population-based studies by linking patient-level data from the Swedish Heart Surgery Register (SWEDEHEART), the National Patient Register, the Cause of Death Register, the National Diabetes Register, the Swedish Renal Registry, the Prescribed Drug Register, and the 2nd version of the Swedish-Danish Scandinavian Donations and Transfusions database. Cross-linking patient-level data is possible through the Personal Identity Number assigned to every individual who has resided in Sweden on a permanent basis. The Swedish Personal Identity Number is the unique identifier in all national registers. Specifically, we aim: 1. To assess the importance of chronic kidney disease for prognosis after CABG. 2. To assess the consequences of acute kidney injury following CABG. 3. To analyze the prognosis in patients with depression prior to CABG. 4. To study risks and benefits of blood transfusions in cardiac surgery. 5. To study the risks associated with diabetes mellitus in cardiac surgery with special reference to type of diabetes (type 1 and type 2) and glycaemic control and duration of disease. 6. To investigate the long-term impact of different surgical strategies (e.g. use of multiple arterial grafts or non-use of cardio-pulmonary bypass) during CABG. 7. To analyze prognosis in relevant sub-populations undergoing CABG (e.g. patients 50 years or younger, possible differences between men and women, and patients with heart failure with preserved vs. reduced ejection fraction). 8. To investigate survival and morbidity in patients between 50 and 69 years undergoing aortic valve replacement with particular reference to prosthesis type (mechanical vs. biological). 9. To analyze the association between socioeconomic factors and prognosis in patients undergoing cardiac surgery. 10. To investigate factors related to durability of bioprosthetic aortic heart valves.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150000
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All adult patients who underwent cardiac surgery in Sweden during the study period Exclusion Criteria: -

Study Design


Intervention

Procedure:
Coronary artery bypass surgery
Primary isolated coronary artery bypass surgery with or without use of cardio-pulmonary bypass
Heart valve surgery
Heart valve surgery, aortic valve replacement or other heart valve procedures

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ulrik Sartipy, MD, PhD Karolinska Institutet

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality 15 years
Secondary Myocardial Infarction 15 years
Secondary Heart Failure 15 years
Secondary Stroke 15 years
Secondary End-Stage Renal Disease 15 years
Secondary Repeat Revascularization 15 years
Secondary Cardiovascular Death 15 years
Secondary Aortic valve reoperation 15 years
Secondary Composite Combined end-point of death and other secondary end-points 15 years
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