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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276950
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Ulrik Sartipy, MD, PhD, Karolinska University Hospital

Tracking Information
First Submitted Date October 25, 2014
First Posted Date October 28, 2014
Last Update Posted Date August 20, 2019
Study Start Date January 2011
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2014)
All-cause mortality [ Time Frame: 15 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2017)
  • 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
Original Secondary Outcome Measures
 (submitted: October 25, 2014)
  • 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 ]
    Combined end-point of death and other secondary end-points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery
Official Title HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery (HARTROCS)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All adult patients who underwent cardiac surgery in Sweden during the study period
Condition
  • Cardiovascular Diseases
  • Kidney Diseases
  • Depression
  • Diabetes Mellitus
Intervention
  • 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 25, 2014)
150000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02276950
Other Study ID Numbers HARTROCS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ulrik Sartipy, MD, PhD, Karolinska University Hospital
Study Sponsor Ulrik Sartipy, MD, PhD
Collaborators 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
PRS Account Karolinska University Hospital
Verification Date August 2019