Carebbean-e: Atrial Fibrillation: Risk and Benefits of Anti-coagulation in the Elderly

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03828162
Collaborator
(none)
2,943
98

Study Details

Study Description

Brief Summary

This study was designed to assess the effectiveness of oral anticoagulants in elderly patients (>=75 years) with atrial fibrillation. All patients discharged from one large hospital in Stockholm, Danderyds Hospital, between november 1st 2010 and december 31st 2017 with atrial fibrillation as main diagnosis have been included (n=2943). Adverse events (cardiovascular death, fatal/non fatal ischemic stroke, peripheral thromboembolism, fatal/non fatal intracerebral hemorrhage and extracranial bleeding) are recorded through linkage to mandatory and qualitative national registries and review of the medical records until december 31 2018.

Detailed Description

The investigators established a prospective cohort of 2943 of elderly (>=75 years old) discharged with atrial fibrillation as main diagnosis from November 1st 2010 to December 31st 2017 from a large hospital in the Northern part of Stockholm in Sweden, Danderyds Hospital. Atrial fibrillation diagnosis is defined by the (ICD-10) codes: I48.0-I48.9 (atrial fibrillation and atrial flutter) according to the International Classification of Diseases, 10th revision. The first admission to the hospital during the study period is recorded as the index admission.

Clinical and anamnestic data, anthropometric measures, biochemical data, treatment at admission and at discharge have been recorded for each patient through the screening of medical journals.

Study Design

Study Type:
Observational
Actual Enrollment :
2943 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Analysis of the Risk and Benefits of Anti-coagulation in Elderly Patients (>=75 Years)
Actual Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Dec 31, 2017
Actual Study Completion Date :
Dec 31, 2018

Outcome Measures

Primary Outcome Measures

  1. Ischemic stroke and peripheral embolism [2011-11-01 to 2018-12-31]

    Ischemic stroke and peripheral embolism have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. Data are extracted from the swedish national patients register.

  2. Bleeding requiring hospitalization [2011-11-01 to 2018-12-31]

    Intracranial and extracranial bleeding have been defined according to the International Classification of Diseases (ICD-10) by the codes: ICD I63-I66. I60, I62, K25.0, K25.2, K25.4, K25.6, K29.0, K65, K92, N02, R19.5, R31, M62.2, N95.0, DR029). Data are extracted from the swedish national patients register.

  3. Cardiovascular death [2011-11-01 to 2018-12-31]

    Cardiovascualr death is defined according to the International Classification of Diseases (ICD-10) by the codes:I00-I99. Data are extracted from the swedish national cause of death register.

Secondary Outcome Measures

  1. Acute coronary syndrome [2011-11-01 to 2018-12-31]

    Acute coronary syndrome have been defined according to the International Classification of Diseases (ICD-10) by the codes: I20-I24. Data are extracted from the swedish national patients register.

Other Outcome Measures

  1. Heart failure [2011-11-01 to 2018-12-31]

    Heart failure has been defined according to the International Classification of Diseases (ICD-10) by the code: I50. Data are extracted from the swedish national patients register.

Eligibility Criteria

Criteria

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

• All consecutive patients discharged with atrial fibrillation as main diagnosis from Danderyds Hospital from November 1st 2011 to December 31 2017 aged 75 years or more.

Exclusion Criteria:
  • Patients who have not given their consensus to the use of medical journals for register based research.

  • Patients who were discharged from the hospital with atrial fibrillation as main diagnosis but were admitted to the hospital for medical reasons unrelated to atrial fibrillation (as an example change of pacemakers batteries).

  • Patients whose medical records are not consistent with the main diagnosis (as an example wrong ICD code).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Bruna Gigante, MD PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bruna Gigante, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03828162
Other Study ID Numbers:
  • OAC and elderly
First Posted:
Feb 4, 2019
Last Update Posted:
Feb 4, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 4, 2019