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Recruiting NCT05237817

Association Between Stroke and Adrenal Incidentalomas

Observational Stroke Adrenal Incidentaloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Adrenal Incidentaloma. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Incidence rate of Adrenal incidentalomas [Time frame: 5 years]
  • Plasma cortisol level [Time frame: 5 years]
Secondary outcome measures (1)
  • Diameter of Adrenal incidentalomas [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Hao Yan — Beijing

Publications

  • 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 34029490
  • 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 33065059
  • 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 27390021

Identifiers

NCT: NCT05237817 · yanh-stroke&adrenal

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗