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Cardiovascular DiseasesHARTROCSNCT02276950

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

An observational study of Cardiovascular Diseases and Kidney Diseases, run by Ulrik Sartipy, MD, PhD.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary artery bypass surgery and Heart valve surgery
Type of treatment
Surgery or procedure
How many people
150,000 participants
Where
No sites listed yet
Study dates
Jan 2011to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • -

About this study

Official title: 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.

Read the 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.
Being tested
Coronary artery bypass surgery, Heart valve surgery
Keywords
Cardiac Surgery, Epidemiologic Methods, Blood Transfusions
Medical subject headings
Cardiovascular Diseases, Kidney Diseases, Depression, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary artery bypass surgeryProcedure or surgery

    Also called CABG

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

  • Heart valve surgeryProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: 15 years

Secondary outcomes (8)

  1. Myocardial Infarction

    Measured: 15 years

  2. Heart Failure

    Measured: 15 years

  3. Stroke

    Measured: 15 years

  4. End-Stage Renal Disease

    Measured: 15 years

  5. Repeat Revascularization

    Measured: 15 years

  6. Cardiovascular Death

    Measured: 15 years

  7. Aortic valve reoperation

    Measured: 15 years

  8. Composite

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

    Measured: 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276950
Sponsor's protocol ID
HARTROCS
Acronym
HARTROCS
Status last verified
Oct 2024
First submitted
25 Oct 2014
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No

Publications

  • Dalen M, Persson M, Glaser N, Sartipy U. Socioeconomic Status and Risk of Bleeding After Mechanical Aortic Valve Replacement. J Am Coll Cardiol. 2022 Jun 28;79(25):2502-2513. doi: 10.1016/j.jacc.2022.04.030.

    PubMed 35738711

  • Glaser N, Persson M, Franco-Cereceda A, Sartipy U. Cause of Death After Surgical Aortic Valve Replacement: SWEDEHEART Observational Study. J Am Heart Assoc. 2021 Nov 16;10(22):e022627. doi: 10.1161/JAHA.121.022627. Epub 2021 Nov 8.

    PubMed 34743549

  • Dalen M, Nielsen S, Ivert T, Holzmann MJ, Sartipy U. Coronary Artery Bypass Grafting in Women 50 Years or Younger. J Am Heart Assoc. 2019 Sep 17;8(18):e013211. doi: 10.1161/JAHA.119.013211. Epub 2019 Sep 14.

    PubMed 31522591

  • Glaser N, Persson M, Jackson V, Holzmann MJ, Franco-Cereceda A, Sartipy U. Loss in Life Expectancy After Surgical Aortic Valve Replacement: SWEDEHEART Study. J Am Coll Cardiol. 2019 Jul 9;74(1):26-33. doi: 10.1016/j.jacc.2019.04.053.

    PubMed 31272548

  • Persson M, Edgren G, Dalen M, Glaser N, Olsson ML, Franco-Cereceda A, Holzmann MJ, Sartipy U. ABO blood type and risk of porcine bioprosthetic aortic valve degeneration: SWEDEHEART observational cohort study. BMJ Open. 2019 May 5;9(5):e029109. doi: 10.1136/bmjopen-2019-029109.

    PubMed 31061061

  • Dalen M, Edgren G, Ivert T, Holzmann MJ, Sartipy U. Weekday and Survival After Cardiac Surgery-A Swedish Nationwide Cohort Study in 106 473 Patients. J Am Heart Assoc. 2017 May 16;6(5):e005908. doi: 10.1161/JAHA.117.005908.

    PubMed 28512116

  • Glaser N, Jackson V, Holzmann MJ, Franco-Cereceda A, Sartipy U. Late Survival After Aortic Valve Replacement in Patients With Moderately Reduced Kidney Function. J Am Heart Assoc. 2016 Dec 17;5(12):e004287. doi: 10.1161/JAHA.116.004287.

    PubMed 27988497

  • Glaser N, Jackson V, Holzmann MJ, Franco-Cereceda A, Sartipy U. Aortic valve replacement with mechanical vs. biological prostheses in patients aged 50-69 years. Eur Heart J. 2016 Sep 7;37(34):2658-67. doi: 10.1093/eurheartj/ehv580. Epub 2015 Nov 11.

    PubMed 26559386

  • Sartipy U, Holzmann MJ, Hjalgrim H, Edgren G. Red Blood Cell Concentrate Storage and Survival After Cardiac Surgery. JAMA. 2015 Oct 20;314(15):1641-3. doi: 10.1001/jama.2015.8690. No abstract available.

    PubMed 26501540

  • Dalen M, Ivert T, Holzmann MJ, Sartipy U. Household Disposable Income and Long-Term Survival After Cardiac Surgery: A Swedish Nationwide Cohort Study in 100,534 Patients. J Am Coll Cardiol. 2015 Oct 27;66(17):1888-97. doi: 10.1016/j.jacc.2015.08.036.

    PubMed 26493661

  • Kuhl J, Sartipy U, Eliasson B, Nystrom T, Holzmann MJ. Relationship between preoperative hemoglobin A1c levels and long-term mortality after coronary artery bypass grafting in patients with type 2 diabetes mellitus. Int J Cardiol. 2016 Jan 1;202:291-6. doi: 10.1016/j.ijcard.2015.09.008. Epub 2015 Sep 12.

    PubMed 26411993

  • Nystrom T, Holzmann MJ, Eliasson B, Kuhl J, Sartipy U. Glycemic Control in Type 1 Diabetes and Long-Term Risk of Cardiovascular Events or Death After Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2015 Aug 4;66(5):535-43. doi: 10.1016/j.jacc.2015.05.054.

    PubMed 26227192

  • Dalen M, Ivert T, Holzmann MJ, Sartipy U. Coronary artery bypass grafting in patients 50 years or younger: a Swedish nationwide cohort study. Circulation. 2015 May 19;131(20):1748-54. doi: 10.1161/CIRCULATIONAHA.114.014335. Epub 2015 Mar 18.

    PubMed 25788458

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Kidney Diseases, run by Ulrik Sartipy, MD, PhD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 15 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276950, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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