## Protocol Section
### Identification Module
**NCT ID:** NCT05446779

**Acronym:** SuddenDeath

**Brief Title:** Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

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

#### Organization Study ID Info
**ID:** THL/5008/5.05.00/2021
#### Organization
**Class:** OTHER
**Full Name:** Helsinki University Central Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-14

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-01-31

**Type:** ACTUAL

#### Start Date
**Date:** 2022-02-03

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2022-07-07
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-22
**Study First Submit QC Date:** 2022-07-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Finnish Institute for Health and Welfare

**Class:** OTHER

**Name:** University of Helsinki

**Class:** OTHER

**Name:** Tampere University Hospital

**Class:** OTHER

**Name:** Tampere University

#### Lead Sponsor

**Class:** OTHER

**Name:** Helsinki University Central Hospital

#### Responsible Party

**Investigator Affiliation:** Helsinki University Central Hospital

**Investigator Full Name:** Niina Matikainen

**Investigator Title:** M.D., Ph.D, , Assoc. Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Primary Aldosteronism

- Adrenal Cushing Syndrome

- Pheochromocytoma

- Endocrine Neoplasia

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining

- Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining

- Diagnostic Test: Histopathological analysis

**Label:** Sudden death

#### Arm Group 2

**Description:** 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

**Intervention Names:**

- Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining

- Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining

- Diagnostic Test: Histopathological analysis

**Label:** Control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control

- Sudden death

**Description:** Immunoshistochemical diagnosis of primary aldosteronism

**Name:** Adrenal aldosterone synthase (CYP11B2) staining

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Control

- Sudden death

**Description:** Immunoshistochemical diagnosis of adrenal hypercortisolism

**Name:** Adrenal cortisol synthase (CYP11B1) staining

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- Control

- Sudden death

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

**Name:** Histopathological analysis

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Histopathological diagnosis of the autopsy

**Measure:** CYP11B2 staining in adrenal glands

**Time Frame:** Through study completion, an average of 2 years

**Description:** Histopathological diagnosis of the autopsy

**Measure:** CYP11B1 staining in adrenal glands

**Time Frame:** Through study completion, an average of 2 years

#### Secondary Outcomes

**Description:** Histopathological diagnosis of the autopsy

**Measure:** CYP11B2 staining in adrenal glands

**Time Frame:** Through study completion, an average of 2 years

**Description:** Histopathological diagnosis of the autopsy

**Measure:** Pheochromocytoma or paraganglioma

**Time Frame:** Through study completion, an average of 2 years

**Description:** Histopathological diagnosis of the autopsy

**Measure:** Neuroendocrine tumor

**Time Frame:** Through study completion, an average of 2 years

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 35 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Helsinki

**Country:** Finland

**Facility:** Endocrinology, Helsinki University Hospital and University of Helsinki

#### Overall Officials

**Official 1:**

**Affiliation:** Helsinki University Central Hospital

**Name:** Niina Matikainen, MD, PhD, Assoc Prof

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000010235

- Term: Paraganglioma

- ID: D000018358

- Term: Neuroendocrine Tumors

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

- ID: D000000308

- Term: Adrenocortical Hyperfunction

- ID: D000000307

- Term: Adrenal Gland Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000003643

- Term: Death

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13578

- Name: Pheochromocytoma

- Relevance: HIGH

- As Found: Pheochromocytoma

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: HIGH

- As Found: Endocrine Neoplasia

- ID: M9980

- Name: Hyperaldosteronism

- Relevance: HIGH

- As Found: Aldosteronism

- ID: M6689

- Name: Cushing Syndrome

- Relevance: HIGH

- As Found: Cushing's Syndrome

- ID: M6847

- Name: Death, Sudden

- Relevance: HIGH

- As Found: Sudden Death

- ID: M13149

- Name: Paraganglioma

- Relevance: LOW

- As Found: Unknown

- ID: M20495

- Name: Neuroendocrine Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M3660

- Name: Adrenocortical Hyperfunction

- Relevance: LOW

- As Found: Unknown

- ID: M3659

- Name: Adrenal Gland Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4530

- Name: Pheochromocytoma

- Relevance: HIGH

- As Found: Pheochromocytoma

- ID: T1679

- Name: Cushing's Syndrome

- Relevance: HIGH

- As Found: Cushing's Syndrome

- ID: T4409

- Name: Paragangliomas 1

- Relevance: LOW

- As Found: Unknown

- ID: T4091

- Name: Neuroendocrine Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

- ID: T2879

- Name: Hyperadrenalism

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010673

- Term: Pheochromocytoma

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000006929

- Term: Hyperaldosteronism

- ID: D000003480

- Term: Cushing Syndrome

- ID: D000003645

- Term: Death, Sudden

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000009184

- Term: Mydriatics

- ID: D000013566

- Term: Sympathomimetics

- ID: D000014662

- Term: Vasoconstrictor Agents

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

### Intervention Browse Module - Browse Leaves

- ID: M7992

- Name: Epinephrine

- Relevance: HIGH

- As Found: Subdural

- ID: M9912

- Name: Hydrocortisone

- Relevance: HIGH

- As Found: 4 years

- ID: M155245

- Name: Hydrocortisone 17-butyrate 21-propionate

- Relevance: LOW

- As Found: Unknown

- ID: M228609

- Name: Hydrocortisone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M263259

- Name: Hydrocortisone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M30371

- Name: Racepinephrine

- Relevance: HIGH

- As Found: Subdural

- ID: M211043

- Name: Epinephryl borate

- Relevance: HIGH

- As Found: Subdural

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12139

- Name: Mydriatics

- Relevance: LOW

- As Found: Unknown

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006854

- Term: Hydrocortisone

- ID: D000004837

- Term: Epinephrine

- ID: D000064705

- Term: Racepinephrine

- ID: C000018285

- Term: Epinephryl borate

### Misc Info Module

- Version Holder: 2024-05-24
