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

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Aldosteronism, Adrenal Cushing Syndrome, Pheochromocytoma, Endocrine Neoplasia

Intervention / Treatment
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* Diagnostic Test: Adrenal aldosterone synthase (CYP11B2) staining
* Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining
* Diagnostic Test: Histopathological analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sudden death<br>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<br>* Immunoshistochemical diagnosis of primary aldosteronism<br>Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining<br>* Immunoshistochemical diagnosis of adrenal hypercortisolism<br>Diagnostic Test: Histopathological analysis<br>* Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism<br>|
| Control<br>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<br>* Immunoshistochemical diagnosis of primary aldosteronism<br>Diagnostic Test: Adrenal cortisol synthase (CYP11B1) staining<br>* Immunoshistochemical diagnosis of adrenal hypercortisolism<br>Diagnostic Test: Histopathological analysis<br>* Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism<br>|

What is the study measuring?
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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 |