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NCT Number: NCT05446779

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Aldosteronism ACTH Syndrome, Ectopic Adrenal Cushing Syndrome Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine Gland Neoplasms Endocrine Neoplasia Endocrine System Diseases Hyperaldosteronism Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pheochromocytoma

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology, Helsinki University Hospital and University of Helsinki

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Consecutive patients with out-of-hospital, sudden death

Exclusion criteria

  • 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

Treatment and study plan

Adrenal aldosterone synthase (CYP11B2) staining

Diagnostic Test

Immunoshistochemical diagnosis of primary aldosteronism

Adrenal cortisol synthase (CYP11B1) staining

Diagnostic Test

Immunoshistochemical diagnosis of adrenal hypercortisolism

Histopathological analysis

Diagnostic Test

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

Primary outcomes

  1. CYP11B2 staining in adrenal glands

    Time frame: Through study completion, an average of 2 years

    Histopathological diagnosis of the autopsy

  2. CYP11B1 staining in adrenal glands

    Time frame: Through study completion, an average of 2 years

    Histopathological diagnosis of the autopsy

Secondary outcomes

  1. CYP11B2 staining in adrenal glands

    Time frame: Through study completion, an average of 2 years

    Histopathological diagnosis of the autopsy

  2. Pheochromocytoma or paraganglioma

    Time frame: Through study completion, an average of 2 years

    Histopathological diagnosis of the autopsy

  3. Neuroendocrine tumor

    Time frame: Through study completion, an average of 2 years

    Histopathological diagnosis of the autopsy

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Institute for Health and Welfare
  • Tampere University
  • Tampere University Hospital
  • University of Helsinki

Registry information

Official study title

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

Acronym: SuddenDeath

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Jul 7, 2022
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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