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

Active, not recruiting

• Conditions: Endocrine Neoplasia; Pheochromocytoma; Primary Aldosteronism; Adrenal Cushing Syndrome
• Interventions: Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining; Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining; Diagnostic Test: Histopathological analysis

• Registration Number: NCT05446779
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-03
• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-07
• Primary Completion: 2023-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sudden death	Histopathological analysis	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
Control	Histopathological analysis	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
Sudden death	Adrenal cortisol synthase (CYP11B1) staining	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
Control	Adrenal aldosterone synthase (CYP11B2) staining	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
Sudden death	Adrenal aldosterone synthase (CYP11B2) staining	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
Control	Adrenal cortisol synthase (CYP11B1) staining	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

Primary Outcome Measures

Name	Time	Method
CYP11B1 staining in adrenal glands	Through study completion, an average of 2 years	Histopathological diagnosis of the autopsy
CYP11B2 staining in adrenal glands	Through study completion, an average of 2 years	Histopathological diagnosis of the autopsy

Secondary Outcome Measures

Name	Time	Method
CYP11B2 staining in adrenal glands	Through study completion, an average of 2 years	Histopathological diagnosis of the autopsy
Pheochromocytoma or paraganglioma	Through study completion, an average of 2 years	Histopathological diagnosis of the autopsy
Neuroendocrine tumor	Through study completion, an average of 2 years	Histopathological diagnosis of the autopsy

Trial Locations

Locations (1)

Endocrinology, Helsinki University Hospital and University of Helsinki; 🇫🇮 Helsinki, Finland