Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

NCT ID: NCT05446779

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-03

Study Completion Date

2026-12-31

Brief Summary

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Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.

Detailed Description

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Conditions

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Primary Aldosteronism Adrenal Cushing Syndrome Pheochromocytoma Endocrine Neoplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sudden death

Unexpected witnessed death occurring within an hour of the onset of symptoms in a person with or without previously known cardiac disease without an extra-cardiac cause, or unexpected unwitnessed death without extra-cardiac cause occurring in the previous 24 hours

Adrenal aldosterone synthase (CYP11B2) staining

Intervention Type DIAGNOSTIC_TEST

Immunoshistochemical diagnosis of primary aldosteronism

Adrenal cortisol synthase (CYP11B1) staining

Intervention Type DIAGNOSTIC_TEST

Immunoshistochemical diagnosis of adrenal hypercortisolism

Histopathological analysis

Intervention Type DIAGNOSTIC_TEST

Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Control

Death because of an exogenic reason for sudden death such as trauma or suicide as a control group i.e. non-disease-induced sudden death

Adrenal aldosterone synthase (CYP11B2) staining

Intervention Type DIAGNOSTIC_TEST

Immunoshistochemical diagnosis of primary aldosteronism

Adrenal cortisol synthase (CYP11B1) staining

Intervention Type DIAGNOSTIC_TEST

Immunoshistochemical diagnosis of adrenal hypercortisolism

Histopathological analysis

Intervention Type DIAGNOSTIC_TEST

Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Interventions

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Adrenal aldosterone synthase (CYP11B2) staining

Immunoshistochemical diagnosis of primary aldosteronism

Intervention Type DIAGNOSTIC_TEST

Adrenal cortisol synthase (CYP11B1) staining

Immunoshistochemical diagnosis of adrenal hypercortisolism

Intervention Type DIAGNOSTIC_TEST

Histopathological analysis

Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Consecutive patients with out-of-hospital, sudden death

Exclusion Criteria

1. Estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown)
2. Terminal disease
3. Institutionalized patients
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Niina Matikainen

M.D., Ph.D, , Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niina Matikainen, MD, PhD, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Endocrinology, Helsinki University Hospital and University of Helsinki

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Ylanen A, Isojarvi J, Virtanen A, Leijon H, Vesterinen T, Aro AL, Huhtala H, Kokko E, Porsti I, Viukari M, Nevalainen PI, Matikainen N. Adrenal aldosterone synthase (CYP11B2) histopathology and its association with disease-induced sudden death: a cross-sectional study. Lancet Reg Health Eur. 2025 Feb 6;51:101226. doi: 10.1016/j.lanepe.2025.101226. eCollection 2025 Apr.

Reference Type DERIVED
PMID: 39995489 (View on PubMed)

Other Identifiers

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THL/5008/5.05.00/2021

Identifier Type: -

Identifier Source: org_study_id

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