NCT02276950

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2011

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2011Dec 2027

Study Start

First participant enrolled

January 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

15.9 years

First QC Date

October 25, 2014

Last Update Submit

October 7, 2024

Conditions

Cardiovascular DiseasesKidney DiseasesDepressionDiabetes Mellitus

Keywords

Cardiac SurgeryEpidemiologic MethodsBlood Transfusions

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    15 years

Secondary Outcomes (8)

  • Myocardial Infarction

    15 years

  • Heart Failure

    15 years

  • Stroke

    15 years

  • End-Stage Renal Disease

    15 years

  • Repeat Revascularization

    15 years

  • +3 more secondary outcomes

Interventions

Coronary artery bypass surgeryPROCEDURE

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

Also known as: CABG
Heart valve surgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 35738711DERIVED

  • 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.

    PMID: 34743549DERIVED

  • 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.

    PMID: 31522591DERIVED

  • 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.

    PMID: 31272548DERIVED

  • 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.

    PMID: 31061061DERIVED

  • 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.

    PMID: 28512116DERIVED

  • 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.

    PMID: 27988497DERIVED

  • 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.

    PMID: 26559386DERIVED

  • 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.

    PMID: 26501540DERIVED

  • 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.

    PMID: 26493661DERIVED

  • 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.

    PMID: 26411993DERIVED

  • 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.

    PMID: 26227192DERIVED

  • 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.

    PMID: 25788458DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesKidney DiseasesDepressionDiabetes Mellitus

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Martin J. Holzmann, MD, PhD

    Karolinska Institutet, Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

  • Ulrik Sartipy, MD, PhD

    Karolinska Institutet, Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 25, 2014

First Posted

October 28, 2014

Study Start

January 1, 2011

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 8, 2024

Record last verified: 2024-10