Routine Cardiac Screening in Sarcoidosis Patients

NCT03902223 | Completed DMC

• 1 other identifier: CSN504-002
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 12

Brief 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

Keywords

sarcoidosis; cardiac sarcoidosis; cardiac sarcoidosis screening

Outcome Measures

Primary Outcomes (3)

• Positive result found from enhanced cardiac sarcoidosis screening at initial visit (sensitivity)

  To evaluate whether second-tier screening tests (echocardiogram and ambulatory ECG) improve the rate of diagnosis of cardiac sarcoidosis beyond conventional screening methods.

  Day 1

• Positive result found on enhanced cardiac screening at month 12 (sensitivity)

  To evaluate whether second-tier screening tests (echocardiogram and ambulatory ECG) improve the rate of diagnosis of cardiac sarcoidosis beyond conventional screening methods during chart review.

  Month 12

• Positive result found from enhanced cardiac screening at month 24 (sensitivity)

  To evaluate the rate of diagnosis of cardiac sarcoidosis in sarcoidosis patients who had initial negative conventional and second-tier screening tests after undergoing these screening tests again at two years

  Month 24

Secondary Outcomes (2)

• Positive result from study cohort

  Up to 120 months after study completion

• Rate of diagnosis of cardiac sarcoidosis during standard of care of patient symptoms and ECG.

  Up to 24 months from day 1

Study Arms (2)

Enhanced Screening Protocol For Cardiac Sarcoidosis

Arm will be randomly assigned to undergo enhanced screening methods (ambulatory ECG and echocardiogram) at month 0 and month 24, as well as a phone call/chart review at month 12.

Diagnostic Test: Enhanced Screening Protocol for Cardiac Sarcoidosis.

Routine Screening for Suspected Cardiac Sarcoidosis

Arm will be randomly assigned for the routine standard of care/no intervention with enhanced screening methods. They will be offered the EKG and symptom check at months 0 and 24, as well as a phone call/chart review at month 12.

Diagnostic Test: Routine Screening for Suspected Cardiac Sarcoidosis

Interventions

Enhanced Screening Protocol for Cardiac Sarcoidosis. DIAGNOSTIC_TEST

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.

Also known as: Echocardiogram and ambulatory ECG

Enhanced Screening Protocol For Cardiac Sarcoidosis

Routine Screening for Suspected Cardiac Sarcoidosis DIAGNOSTIC_TEST

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

Also known as: Symptom check and standard ECG.

Routine Screening for Suspected Cardiac Sarcoidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with both suspected sarcoidosis and confirmed diagnosis

You may qualify if:

• Diagnosis of sarcoidosis as per The American Thoracic Society guidelines
• First visit to the enrolling center
• Intent to continue care at the enrolling center at least annually

You may not qualify if:

• Referred to the enrolling center to evaluate for suspected cardiac sarcoidosis.
• Pre-existing high suspicion for cardiac sarcoidosis, defined as having had cardiac MRI or cardiac PET scan, even if it was ordered by other institutions.
• Severe sarcoidosis or other disease conferring a high likelihood of death or transplant within the next year
• Unwilling or unable to undergo echocardiography and ambulatory ECG

Sponsors & Collaborators

• Foundation for Sarcoidosis Research: lead

Study Sites (12)

National Jewish Health

Denver, Colorado, 80206, United States

Location

Northwestern University Medicine

Chicago, Illinois, 60611, United States

Location

University of Illinois Medical Center At Chicago

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

St. Antonius

Amsterdam, Nieuwegein, Netherlands

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

Echocardiography; Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrocardiography; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Dan Culver, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Muhunthan Thillai, MBBS

  Royal Papworth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 3, 2019
• Study Start: April 5, 2019
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); US (10); GB (1)