Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02276950

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiovascular Diseases Behavior Behavioral Symptoms Depression Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

  • To assess the importance of chronic kidney disease for prognosis after CABG.
  • To assess the consequences of acute kidney injury following CABG.
  • To analyze the prognosis in patients with depression prior to CABG.
  • To study risks and benefits of blood transfusions in cardiac surgery.
  • 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.
  • 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.
  • 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).
  • 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).
  • To analyze the association between socioeconomic factors and prognosis in patients undergoing cardiac surgery.
  • To investigate factors related to durability of bioprosthetic aortic heart valves.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Coronary artery bypass surgery

Procedure

Primary isolated coronary artery bypass surgery with or without use of cardio-pulmonary bypass

Other names: CABG

Heart valve surgery

Procedure

Heart valve surgery, aortic valve replacement or other heart valve procedures

Primary outcomes

  1. All-cause mortality

    Time frame: 15 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ulrik Sartipy, MD, PhD

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: HARTROCS

Important dates

Study start
2011
Primary completion
2026
Study completion
2027
First posted
Oct 28, 2014
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.