Overview

This trial is active, not recruiting.

Conditions cardiovascular diseases, kidney diseases, depression, diabetes mellitus
Treatments coronary artery bypass surgery, heart valve surgery
Sponsor Ulrik Sartipy, MD, PhD
Collaborator Karolinska Institutet
Start date January 2011
End date March 2018
Trial size 150000 participants
Trial identifier NCT02276950, HARTROCS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
All-cause mortality
time frame: 15 years

Secondary Outcomes

Measure
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
Composite
time frame: 15 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: All adult patients who underwent cardiac surgery in Sweden during the study period Exclusion Criteria:

Additional Information

Official title HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)
Principal investigator Martin J. Holzmann, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.