Clinical trial NCT05237817: Association Between Stroke and Adrenal Incidentalomas
Official title: If Adrenal Incidentalomas Have the Influences to Occur and Progress in Patients With Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Adrenal Incidentaloma
Keywords: Adrenal Incidentaloma
Autonomous cortisol secretion
Stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Stroke disease, and erolled in our emergency or clinical department.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence rate of Adrenal incidentalomas
timeFrame: 5 years
measure: Plasma cortisol level
timeFrame: 5 years
Secondary outcomes:
measure: Diameter of Adrenal incidentalomas
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hao Yan
Study officials:
affiliation: Department of Urology, Xuanwu Hospital, Capital Medical University
name: Tong W Ou, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.