Routine Cardiac Screening in Sarcoidosis Patients

Summary

This protocol is an unblended randomized screening trial will have consecutive patients with no suggestion of cardiac sarcoidosis according to usual screening enroll in an enhanced screening protocol. The routine clinical care is to gather patient's history of symptoms and under go an ECG. If a patient has an abnormal results in standard screening, they typically have further evaluations as part of their routine medical care. These tests might include an echocardiogram, ambulatory ECG, and advanced cardiac imaging (MRI, PET scan as per local practice). A patient that has normal results on standard screening will be randomly assigned to enhanced screening at each center. Half the patients will be randomized to usual follow-up (annual symptom assessment and ECG) and the other half will be assigned to the enhanced screening (echocardiogram and ambulatory ECG at enrollment and at 24 months).

The investigators hypothesize that screening using conventional history, physical and ECG in the general sarcoidosis population, followed by appropriate advanced imaging testing, will result in the identification of a higher percentage of ascertained cardiac sarcoidosis than has been reported historically (2-5%). The investigators hypothesize that routine use of echocardiogram with strain and ambulatory ECG will identify additional patients who will have advanced imaging abnormalities or who meet criteria for cardiac sarcoidosis. The investigators further hypothesize that re-screening patients after 24 months with repeat echocardiogram and ambulatory ECG will identify additional patients with suspicion for cardiac sarcoidosis who had no abnormalities on the standard screening tests.

Conditions

• Sarcoidosis
• Cardiac Sarcoidosis
• Boeck's Disease
• Besnier-Boeck Disease

Interventions

DIAGNOSTIC_TEST

Enhanced Screening Protocol for Cardiac Sarcoidosis.

To utilize enhanced screening tests for cardiac sarcoidosis in an undiagnosed and potentially under-diagnosed patient population to determine the rate of missed cardiac sarcoidosis diagnosis. Following testing by the standard screening tests, this intervention includes a subsequent echocardiogram and a wearable ECG, also known as a Holter Monitor or ambulatory ECG.

DIAGNOSTIC_TEST

Routine Screening for Suspected Cardiac Sarcoidosis

To utilize standard of care screening tests for cardiac sarcoidosis. This includes symptom check and a standard ECG.

Sponsors & Collaborators

• Foundation for Sarcoidosis Research

  lead OTHER

Principal Investigators

• Dan Culver, DO · The Cleveland Clinic

• Muhunthan Thillai, MBBS · Royal Papworth Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-05

Primary Completion

2024-11-01

Completion

2024-11-01

Countries

• United States
• Netherlands
• United Kingdom

Study Locations