HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery

Depression Clinical Trial

— HARTROCS  

Official title:

HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02276950
• Other study ID #: HARTROCS
• Status: Active, not recruiting
• 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
• 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:

-

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Diabetes Mellitus
• Kidney Diseases

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