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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Primary Aldosteronism; Pheochromocytoma; Adrenal Cushing Syndrome; Endocrine Neoplasia
• Intervention / Treatment: Diagnostic test: Adrenal aldosterone synthase (CYP11B2) staining; Diagnostic test: Adrenal cortisol synthase (CYP11B1) staining; Diagnostic test: Histopathological analysis

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Niina Matikainen, MD, PhD, Assoc Prof; Phone Number: +358-9-4711; Email: niina.matikainen@hus.fi
• Study Contact Backup: Name: Marianna Viukari, MD, PhD; Phone Number: +358-9-4711

Study Locations

• Finland
  • Helsinki, Finland
    • Endocrinology, Helsinki University Hospital and University of Helsinki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Immunoshistochemical diagnosis of primary aldosteronism; Diagnostic test: Adrenal cortisol synthase (CYP11B1) staining; Immunoshistochemical diagnosis of adrenal hypercortisolism; Diagnostic test: Histopathological analysis; 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	Diagnostic test: Adrenal aldosterone synthase (CYP11B2) staining; Immunoshistochemical diagnosis of primary aldosteronism; Diagnostic test: Adrenal cortisol synthase (CYP11B1) staining; Immunoshistochemical diagnosis of adrenal hypercortisolism; Diagnostic test: Histopathological analysis; Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Tampere University; Tampere University Hospital; Finnish Institute for Health and Welfare
• Investigators: Principal Investigator: Niina Matikainen, MD, PhD, Assoc Prof, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Death; Neuroendocrine Tumors; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Paraganglioma; Hyperaldosteronism; Endocrine Gland Neoplasms; Cushing Syndrome; Pheochromocytoma; Death, Sudden; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Racepinephrine; Epinephryl borate; Hydrocortisone
• Other Study ID Numbers: THL/5008/5.05.00/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No