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

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05446779
Acronym
SuddenDeath
Enrollment
400
Registered
2022-07-07
Start date
2022-02-03
Completion date
2026-12-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism, Adrenal Cushing Syndrome, Pheochromocytoma, Endocrine Neoplasia

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.

Interventions

DIAGNOSTIC_TESTAdrenal aldosterone synthase (CYP11B2) staining

Immunoshistochemical diagnosis of primary aldosteronism

DIAGNOSTIC_TESTAdrenal cortisol synthase (CYP11B1) staining

Immunoshistochemical diagnosis of adrenal hypercortisolism

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

Sponsors

Finnish Institute for Health and Welfare
CollaboratorOTHER_GOV
University of Helsinki
CollaboratorOTHER
Tampere University Hospital
CollaboratorOTHER
Tampere University
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CYP11B2 staining in adrenal glandsThrough study completion, an average of 2 yearsHistopathological diagnosis of the autopsy
CYP11B1 staining in adrenal glandsThrough study completion, an average of 2 yearsHistopathological diagnosis of the autopsy

Secondary

MeasureTime frameDescription
CYP11B2 staining in adrenal glandsThrough study completion, an average of 2 yearsHistopathological diagnosis of the autopsy
Pheochromocytoma or paragangliomaThrough study completion, an average of 2 yearsHistopathological diagnosis of the autopsy
Neuroendocrine tumorThrough study completion, an average of 2 yearsHistopathological diagnosis of the autopsy

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026