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

NCT05446779 | Active Not Recruiting

• 1 other identifier: THL/5008/5.05.00/2021
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Aldosteronism; Adrenal Cushing Syndrome; Pheochromocytoma; Endocrine Neoplasia

Outcome Measures

Primary Outcomes (2)

• CYP11B2 staining in adrenal glands

  Histopathological diagnosis of the autopsy

  Through study completion, an average of 2 years

• CYP11B1 staining in adrenal glands

  Histopathological diagnosis of the autopsy

  Through study completion, an average of 2 years

Secondary Outcomes (3)

• CYP11B2 staining in adrenal glands

  Through study completion, an average of 2 years

• Pheochromocytoma or paraganglioma

  Through study completion, an average of 2 years

• Neuroendocrine tumor

  Through study completion, an average of 2 years

Study Arms (2)

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

Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining; Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining; Diagnostic Test: Histopathological analysis

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

Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining; Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining; Diagnostic Test: Histopathological analysis

Interventions

Adrenal aldosterone synthase (CYP11B2) staining DIAGNOSTIC_TEST

Immunoshistochemical diagnosis of primary aldosteronism

Control; Sudden death

Adrenal cortisol synthase (CYP11B1) staining DIAGNOSTIC_TEST

Immunoshistochemical diagnosis of adrenal hypercortisolism

Control; Sudden death

Histopathological analysis DIAGNOSTIC_TEST

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

Control; Sudden death

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We enroll aproximately 200 consecutive patients with out-of-hospital, sudden death to both groups.

You may qualify if:

• Consecutive patients with out-of-hospital, sudden death

You may not qualify if:

• 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)
• Terminal disease
• Institutionalized patients

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Finnish Institute for Health and Welfare: collaborator
• University of Helsinki: collaborator
• Tampere University Hospital: collaborator
• Tampere University: collaborator

Study Sites (1)

Endocrinology, Helsinki University Hospital and University of Helsinki

Helsinki, Finland

Location

Related Publications (1)

• 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.

  PMID: 39995489 DERIVED

MeSH Terms

Conditions

Hyperaldosteronism; ACTH Syndrome, Ectopic; Pheochromocytoma; Endocrine Gland Neoplasms

Interventions

Staining and Labeling

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques

Study Officials

• Niina Matikainen, MD, PhD, Assoc Prof

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D, , Assoc. Prof.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 7, 2022
• Study Start: February 3, 2022
• Primary Completion: January 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

FI (1)