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

Sponsor
Ulrik Sartipy, MD, PhD (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02276950
Collaborator
Karolinska Institutet (Other)
150,000
179

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Jan 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Outcome Measures

Primary Outcome Measures

  1. All-cause mortality [15 years]

Secondary Outcome Measures

  1. Myocardial Infarction [15 years]

  2. Heart Failure [15 years]

  3. Stroke [15 years]

  4. End-Stage Renal Disease [15 years]

  5. Repeat Revascularization [15 years]

  6. Cardiovascular Death [15 years]

  7. Aortic valve reoperation [15 years]

  8. Composite [15 years]

    Combined end-point of death and other secondary end-points

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ulrik Sartipy, MD, PhD, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT02276950
Other Study ID Numbers:
  • HARTROCS
First Posted:
Oct 28, 2014
Last Update Posted:
Mar 29, 2022
Last Verified:
Mar 1, 2022
Keywords provided by Ulrik Sartipy, MD, PhD, MD, PhD, Karolinska University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2022