NCT05237817

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
34mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress64%
Apr 2021Feb 2029

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Expected
Last Updated

February 14, 2022

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

November 1, 2021

Last Update Submit

February 8, 2022

Conditions

StrokeAdrenal Incidentaloma

Keywords

Adrenal IncidentalomaAutonomous cortisol secretionStroke

Outcome Measures

Primary Outcomes (2)

  • Incidence rate of Adrenal incidentalomas

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

    5 years

  • Plasma cortisol level

    Plasma cortisol level after a 1-mg dexamethasone suppression test

    5 years

Secondary Outcomes (1)

  • Diameter of Adrenal incidentalomas

    5 years

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • stroke disease , such as Cerebral infarction、Intracerebral hemorrhage and Subarachnoid hemorrhage.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hao Yan

Beijing, 100053, China

RECRUITING

Related Publications (3)

  • Kjellbom A, Lindgren O, Puvaneswaralingam S, Londahl M, Olsen H. Association Between Mortality and Levels of Autonomous Cortisol Secretion by Adrenal Incidentalomas : A Cohort Study. Ann Intern Med. 2021 Aug;174(8):1041-1049. doi: 10.7326/M20-7946. Epub 2021 May 25.

    PMID: 34029490BACKGROUND

  • Ebbehoj A, Li D, Kaur RJ, Zhang C, Singh S, Li T, Atkinson E, Achenbach S, Khosla S, Arlt W, Young WF, Rocca WA, Bancos I. Epidemiology of adrenal tumours in Olmsted County, Minnesota, USA: a population-based cohort study. Lancet Diabetes Endocrinol. 2020 Nov;8(11):894-902. doi: 10.1016/S2213-8587(20)30314-4.

    PMID: 33065059BACKGROUND

  • Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.

    PMID: 27390021BACKGROUND

MeSH Terms

Conditions

StrokeAdrenal incidentaloma

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tong W Ou, Dr.

    Department of Urology, Xuanwu Hospital, Capital Medical University

    STUDY DIRECTOR

Central Study Contacts

Hao Yan, Dr.

CONTACT

+86-13651341058yanhurology@qq.com

Tong W Ou, Dr.

CONTACT

outongwen@sohu.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

February 14, 2022

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion (Estimated)

February 28, 2029

Last Updated

February 14, 2022

Record last verified: 2021-04

Locations

CN(1)