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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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Ulrik Sartipy, MD, PhD, Karolinska University Hospital

Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Kidney Diseases Depression Diabetes Mellitus Procedure: Coronary artery bypass surgery Procedure: Heart valve surgery

Detailed 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.

Study Type : Observational
Estimated Enrollment : 150000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery


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


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 15 years ]

Secondary Outcome Measures :
  1. Myocardial Infarction [ Time Frame: 15 years ]
  2. Heart Failure [ Time Frame: 15 years ]
  3. Stroke [ Time Frame: 15 years ]
  4. End-Stage Renal Disease [ Time Frame: 15 years ]
  5. Repeat Revascularization [ Time Frame: 15 years ]
  6. Cardiovascular Death [ Time Frame: 15 years ]
  7. Aortic valve reoperation [ Time Frame: 15 years ]
  8. Composite [ Time Frame: 15 years ]
    Combined end-point of death and other secondary end-points



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients who underwent cardiac surgery in Sweden during the study period
Criteria

Inclusion Criteria:

All adult patients who underwent cardiac surgery in Sweden during the study period

Exclusion Criteria:


Information from the National Library of Medicine

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


Sponsors and Collaborators
Ulrik Sartipy, MD, PhD
Karolinska Institutet
Investigators
Principal Investigator: Martin J. Holzmann, MD, PhD Karolinska Institutet, Karolinska University Hospital
Principal Investigator: Ulrik Sartipy, MD, PhD Karolinska Institutet, Karolinska University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ulrik Sartipy, MD, PhD, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02276950     History of Changes
Other Study ID Numbers: HARTROCS
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Keywords provided by Ulrik Sartipy, MD, PhD, Karolinska University Hospital:
Cardiac Surgery
Epidemiologic Methods
Blood Transfusions

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases