HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)
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|ClinicalTrials.gov Identifier: NCT02276950|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Kidney Diseases Depression Diabetes Mellitus||Procedure: Coronary artery bypass surgery Procedure: Heart valve surgery|
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:
- To assess the importance of chronic kidney disease for prognosis after CABG.
- To assess the consequences of acute kidney injury following CABG.
- To analyze the prognosis in patients with depression prior to CABG.
- To study risks and benefits of blood transfusions in cardiac surgery.
- 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.
- 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.
- 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).
- 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).
- To analyze the association between socioeconomic factors and prognosis in patients undergoing cardiac surgery.
- To investigate factors related to durability of bioprosthetic aortic heart valves.
|Study Type :||Observational|
|Estimated Enrollment :||150000 participants|
|Official Title:||HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2020|
- Procedure: Coronary artery bypass surgery
Primary isolated coronary artery bypass surgery with or without use of cardio-pulmonary bypassOther Name: CABG
- Procedure: Heart valve surgery
Heart valve surgery, aortic valve replacement or other heart valve procedures
- All-cause mortality [ Time Frame: 15 years ]
- Myocardial Infarction [ Time Frame: 15 years ]
- Heart Failure [ Time Frame: 15 years ]
- Stroke [ Time Frame: 15 years ]
- End-Stage Renal Disease [ Time Frame: 15 years ]
- Repeat Revascularization [ Time Frame: 15 years ]
- Cardiovascular Death [ Time Frame: 15 years ]
- Aortic valve reoperation [ Time Frame: 15 years ]
- Composite [ Time Frame: 15 years ]Combined end-point of death and other secondary end-points
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276950
|Principal Investigator:||Martin J. Holzmann, MD, PhD||Karolinska Institutet, Karolinska University Hospital|
|Principal Investigator:||Ulrik Sartipy, MD, PhD||Karolinska Institutet, Karolinska University Hospital|