Actively Recruiting

Age: 18Years - 100Years
All Genders
ID05237817

Influence of Adrenal Incidentalomas on Occurrence and Progression in Stroke Patients

Led by Xuanwu Hospital, Beijing · Updated on 2022-02-14

2

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the link between adrenal incidentalomas (AIs), which are unexpected adrenal gland growths found during imaging done for reasons other than adrenal disease, and stroke. Stroke is a serious condition that can cause disability and death worldwide. This study aims to understand the risk of disability and death in stroke patients who also have AIs, focusing on how stroke and levels of autonomous cortisol secretion relate in these patients. The study has two parts: a retrospective cohort study conducted from April to September 2021, and a prospective cohort study planned from March 2022 to February 2024. Patients with different types of stroke—cerebral infarction, intracerebral hemorrhage, and subarachnoid hemorrhage—are enrolled from emergency or clinical departments. In the prospective part, patients will have their plasma cortisol levels measured after a 1-mg dexamethasone suppression test. Researchers will record detailed information about the stroke, patient characteristics, and AIs in both study parts. Participants will be monitored for up to five years to assess the incidence rate of adrenal incidentalomas and plasma cortisol levels as primary outcomes. Secondary outcomes include measuring the size of adrenal incidentalomas. Data collection includes detailed patient and disease characteristics, and assessments are performed to understand the progression and impact of AIs in stroke patients. This study does not involve interventions but observes the natural course and associations over time.

CONDITIONS

Brief Title

Association Between Stroke and Adrenal Incidentalomas

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 100 years
  • Diagnosed with stroke, including cerebral infarction, intracerebral hemorrhage, or subarachnoid hemorrhage
  • Enrollment from emergency or clinical departments
Not Eligible

You will not qualify if you...

  • Presence of metastatic cancer
  • Adrenal incidentalomas smaller than 1 cm
  • Nonadenoma adrenal lesions such as myelolipomas, hemorrhages, or cysts
  • Oral glucocorticoid treatment exceeding a single dose in the past 3 months
  • Use of inhaled steroids or medications affecting dexamethasone metabolism
  • Systemic estrogen treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Initial assessments occur at enrollment

Participants undergo imaging and blood tests to assess adrenal incidentalomas and plasma cortisol levels after a 1-mg dexamethasone suppression test.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants with stroke are observed for the incidence rate and characteristics of adrenal incidentalomas and plasma cortisol levels.

Follow-up assessments as per routine clinical care

Trial Site Locations

Total: 1 location

1

Hao Yan

Beijing, China, 100053

Actively Recruiting

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Research Team

H

Hao Yan, Dr.

T

Tong W Ou, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Association Between Mortality and Levels of Autonomous Cortisol Secretion by Adrenal Incidentalomas : A Cohort Study.

Albin Kjellbom, Ola Lindgren, Shobitha Puvaneswaralingam...

https://pubmed.ncbi.nlm.nih.gov/34029490

Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors.

Martin Fassnacht, Wiebke Arlt, Irina Bancos...

https://pubmed.ncbi.nlm.nih.gov/27390021