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

October 7, 2024 updated by: Ulrik Sartipy, MD, PhD

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

150000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 15 years
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Infarction
Time Frame: 15 years
15 years
Heart Failure
Time Frame: 15 years
15 years
Stroke
Time Frame: 15 years
15 years
End-Stage Renal Disease
Time Frame: 15 years
15 years
Repeat Revascularization
Time Frame: 15 years
15 years
Cardiovascular Death
Time Frame: 15 years
15 years
Aortic valve reoperation
Time Frame: 15 years
15 years
Composite
Time Frame: 15 years
Combined end-point of death and other secondary end-points
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 25, 2014

First Submitted That Met QC Criteria

October 25, 2014

First Posted (Estimated)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HARTROCS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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