StrokeABSAINCT05237817
Association Between Stroke and Adrenal Incidentalomas
An observational study of Stroke and Adrenal Incidentaloma, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Adrenal Incidentaloma
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 28 Feb 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stroke disease, and erolled in our emergency or clinical department.
Who may be able to join
- stroke disease , such as Cerebral infarction、Intracerebral hemorrhage and Subarachnoid hemorrhage.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tong W Ou, Dr. contact
China1 site, 1 recruiting
- Recruiting
Hao Yan
Beijing, 100053
Hao Yan, Dr., 86-13651341058, yanhurology@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Adrenal Incidentaloma
- Keywords
- Adrenal Incidentaloma, Autonomous cortisol secretion, Stroke
- Medical subject headings
- Stroke, Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Adrenal incidentalomas
Assess the standardised incidence rate of AIs in all patients with stroke
Measured: 5 years
Plasma cortisol level
Plasma cortisol level after a 1-mg dexamethasone suppression test
Measured: 5 years
Secondary outcomes (1)
Diameter of Adrenal incidentalomas
Maximal axial diameter of adrenal incidentalomas by computed tomography scan; Millimetre as a metric unit of length in this study
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tong W Ou, Dr., Study director, Department of Urology, Xuanwu Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237817
- Sponsor's protocol ID
- yanh-stroke&adrenal
- Acronym
- ABSAI
- Status last verified
- Apr 2021
- First submitted
- 1 Nov 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: un-decided if corporation for multi-centers study in the future.
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.
PubMed 34029490Ebbehoj 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.
PubMed 33065059Fassnacht 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.
PubMed 27390021
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- If Adrenal Incidentalomas Have the Influences to Occur and Progress in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05237817
- Acronym / sponsor ID
- ABSAI / yanh-stroke&adrenal
- Conditions
- Stroke, Adrenal Incidentaloma
- Keywords
- Adrenal Incidentaloma, Autonomous cortisol secretion, Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stroke disease, and erolled in our emergency or clinical department.
Key inclusion criteria (1 listed)
- stroke disease , such as Cerebral infarction、Intracerebral hemorrhage and Subarachnoid hemorrhage.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence rate of Adrenal incidentalomas
Time frame: 5 years
Assess the standardised incidence rate of AIs in all patients with stroke
Plasma cortisol level
Time frame: 5 years
Plasma cortisol level after a 1-mg dexamethasone suppression test
1 secondary outcome
Diameter of Adrenal incidentalomas
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 34029490Kjellbom 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.
- Background: PubMed 33065059Ebbehoj 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.
- Background: PubMed 27390021Fassnacht 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.
- Individual participant dataSharing planned: Undecided. un-decided if corporation for multi-centers study in the future.
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tong W Ou, Dr. contact
Tong W Ou, Dr. study director
Department of Urology, Xuanwu Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Adrenal Incidentaloma, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Yan, Dr. (+86-13651341058, yanhurology@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of Adrenal incidentalomas (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05237817, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.