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

Pheochromocytoma Clinical Trial

— SuddenDeath  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05446779
• Other study ID #: THL/5008/5.05.00/2021
• Status: Active, not recruiting
• Start date: February 3, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 31, 2026
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cushing Syndrome
• Death, Sudden
• Endocrine Gland Neoplasms
• Endocrine Neoplasia
• Hyperaldosteronism
• Pheochromocytoma
• Primary Aldosteronism

Intervention

Diagnostic Test:
• Adrenal aldosterone synthase (CYP11B2) staining
Immunoshistochemical diagnosis of primary aldosteronism
• Adrenal cortisol synthase (CYP11B1) staining
Immunoshistochemical diagnosis of adrenal hypercortisolism
• Histopathological analysis
Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Locations

Country	Name	City	State
Finland	Endocrinology, Helsinki University Hospital and University of Helsinki	Helsinki

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finnish Institute for Health and Welfare, Tampere University, Tampere University Hospital, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CYP11B2 staining in adrenal glands	Histopathological diagnosis of the autopsy	Through study completion, an average of 2 years
Primary	CYP11B1 staining in adrenal glands	Histopathological diagnosis of the autopsy	Through study completion, an average of 2 years
Secondary	CYP11B2 staining in adrenal glands	Histopathological diagnosis of the autopsy	Through study completion, an average of 2 years
Secondary	Pheochromocytoma or paraganglioma	Histopathological diagnosis of the autopsy	Through study completion, an average of 2 years
Secondary	Neuroendocrine tumor	Histopathological diagnosis of the autopsy	Through study completion, an average of 2 years