Association Between Stroke and Adrenal Incidentalomas (ABSAI)

February 8, 2022 updated by: Xuanwu Hospital, Beijing

If Adrenal Incidentalomas Have the Influences to Occur and Progress in Patients With Stroke

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Hao Yan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Stroke disease, and erolled in our emergency or clinical department.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of Adrenal incidentalomas
Time Frame: 5 years
Assess the standardised incidence rate of AIs in all patients with stroke
5 years
Plasma cortisol level
Time Frame: 5 years
Plasma cortisol level after a 1-mg dexamethasone suppression test
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diameter of Adrenal incidentalomas
Time Frame: 5 years
Maximal axial diameter of adrenal incidentalomas by computed tomography scan; Millimetre as a metric unit of length in this study
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

February 28, 2029

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yanh-stroke&adrenal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

un-decided if corporation for multi-centers study in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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