ABSAI: Association Between Stroke and Adrenal Incidentalomas

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Recruiting
CT.gov ID
NCT05237817
Collaborator
(none)
2
1
94.9
0

Study Details

Study Description

Brief Summary

Adrenal incidentalomas (AIs) are commonly encountered in transsection imaging which purpose not for suspected adrenal disease. However, part of AIs in patients is associated with Stroke. Stroke is a diseases which could cause of disability and death worldwide. In clinical practice, detailed information about the association between stroke and AIs is not available. In this study, the investigators aimed to investigate the risk for disability and death in the large group of stroke patients with AIs.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Background:

    Adrenal incidentalomas (AIs) are commonly encountered in transsection imaging which purpose not for suspected adrenal disease. However, part of AIs in patients is associated with Stroke . The investigators aimed to investigate the risk for disability and death in the large group of stroke patients with AIs.

    Objective:

    To measure the association between stroke and levels of autonomous cortisol secretion in patients with AIs.

    Design:

    Part 1, Retrospective cohort study.

    From April 1, 2021, to September 30, 2021, cohort patients with stroke were recruited in this study. The investigators assess the standardised incidence rate of AIs in all patients. Meanwhile, detail information about stroke disease、patient and AIs characteristics were record.

    Part 2, Prospective cohort study.

    From Mar 1, 2022, to Feb 29, 2024, cohort patients with stroke plane to recruit in this study. All patient receive the plasma cortisol level after a 1-mg dexamethasone suppression test. The investigators assess the standardised incidence rate of AIs in all patients. Meanwhile, detail information about stroke disease、patient and AIs characteristics would be record.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    If Adrenal Incidentalomas Have the Influences to Occur and Progress in Patients With Stroke
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Feb 28, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Cerebral infarction Group

    Patients with cerebral infarction, and enrolled in our emergency or clinical department.

    Intracerebral hemorrhage Group

    Patients with intracerebral hemorrhage, and enrolled in our emergency or clinical department.

    Subarachnoid hemorrhage Group

    Patients with subarachnoid hemorrhage, and enrolled in our emergency or clinical department.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rate of Adrenal incidentalomas [5 years]

      Assess the standardised incidence rate of AIs in all patients with stroke

    2. Plasma cortisol level [5 years]

      Plasma cortisol level after a 1-mg dexamethasone suppression test

    Secondary Outcome Measures

    1. Diameter of Adrenal incidentalomas [5 years]

      Maximal axial diameter of adrenal incidentalomas by computed tomography scan; Millimetre as a metric unit of length in this study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • stroke disease , such as Cerebral infarction、Intracerebral hemorrhage and Subarachnoid hemorrhage.
    Exclusion Criteria:
    • presence of metastatic cancer;

    • AIs smaller than 1 cm;

    • nonadenoma lesions, such as myelolipomas,hemorrhages, and cysts;

    • oral glucocorticoid treatment with more than single doses in the past 3 months;

    • use of inhaled steroids or medication affecting dexamethasone metabolism;

    • systemic estrogen treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hao Yan Beijing China 100053

    Sponsors and Collaborators

    • Xuanwu Hospital, Beijing

    Investigators

    • Study Director: Tong W Ou, Dr., Department of Urology, Xuanwu Hospital, Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xuanwu Hospital, Beijing
    ClinicalTrials.gov Identifier:
    NCT05237817
    Other Study ID Numbers:
    • yanh-stroke&adrenal
    First Posted:
    Feb 14, 2022
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xuanwu Hospital, Beijing
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2022