Enhanced Screening Protocol for Cardiac Sarcoidosis. for Sarcoidosis

1
Effectiveness
1
Safety
St. Antonius, Koekoekslaan, Netherlands
Sarcoidosis+3 More
Enhanced Screening Protocol for Cardiac Sarcoidosis. - DiagnosticTest
Eligibility
18+
All Sexes
Eligible conditions
Sarcoidosis

Study Summary

Routine Cardiac Screening in Sarcoidosis Patients

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Enhanced Screening Protocol for Cardiac Sarcoidosis. will improve 3 primary outcomes and 2 secondary outcomes in patients with Sarcoidosis. Measurement will happen over the course of Day 1.

Day 1
Positive result found from enhanced cardiac sarcoidosis screening at initial visit (sensitivity)
Month 12
Positive result found on enhanced cardiac screening at month 12 (sensitivity)
Month 24
Positive result found from enhanced cardiac screening at month 24 (sensitivity)
Month 120
Positive result from study cohort
Month 24
Rate of diagnosis of cardiac sarcoidosis during standard of care of patient symptoms and ECG.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Routine Screening for Suspected Cardiac Sarcoidosis
Enhanced Screening Protocol For Cardiac Sarcoidosis

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Enhanced Screening Protocol For Cardiac Sarcoidosis. is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Enhanced Screening Protocol For Cardiac Sarcoidosis
DiagnosticTest
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.
Routine Screening for Suspected Cardiac Sarcoidosis
DiagnosticTest
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 120 months after study completion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 120 months after study completion for reporting.

Closest Location

Albany Medical Center - Albany, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I had my first visit to the enrolling center today show original
I will continue to go to the enrolling center at least once a year. show original
The American Thoracic Society has published guidelines for the diagnosis of sarcoidosis show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can sarcoidosis be cured?

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No evidence indicates that sarcoidosis can be cured, although many sarcoidosis patients reported a significant improvement in their symptoms after 5- to 7 years of treatment with steroids.

Unverified Answer

What is sarcoidosis?

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Sarcoidosis, a systemic disease of unknown cause, has been considered as a complication of tuberculosis. Present clinical descriptions of sarcoidosis are not precise, because of the heterogeneity of the disease observed in all patients.

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What causes sarcoidosis?

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There is no single 'cause' of sarcoidosis, but an association between radiological granulomatous changes and antigen-positive T-helper type 1 (Th1) immune responses has been demonstrated. As such, the most important steps in the pathophysiology of sarcoidosis are the mechanisms involved in the modulation of the Th1 cell response. This in turn can be affected by abnormalities in the genes encoding cytokines, which are known to be involved in the pathogenesis of sarcoidosis. Furthermore, the role of the HLA-DR alpha chain in disease susceptibility and T helper cell cytokine expression is well established.

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How many people get sarcoidosis a year in the United States?

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For at least the last two decades, sarcoidosis has been increasing in incidence and morbidity in the US, in parallel with the increasing incidence of cigarette smoking.

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What are common treatments for sarcoidosis?

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Although some treatments have been used for sarcoidosis, no standard treatment is available. Treatment may include long term corticosteroids, immunosuppressants, and even lung resection. Corticosteroids are effective and well tolerated in cases of pulmonary sarcoidosis\n

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What are the signs of sarcoidosis?

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Some signs of sarcoidosis that lead to diagnosis include: bilateral hilar lymphadenopathy, erythema nodosum, arthritis or erythema nodosum. In many cases, these signs are encountered in the setting of biopsy proven sarcoidosis. Furthermore, many patients who develop sarcoidosis are under the age of 50 and present with extrapulmonary symptoms not previously associated with sarcoidosis.\n

Unverified Answer

What is enhanced screening protocol for cardiac sarcoidosis.?

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A cardiac sarcoidosis diagnostic algorithm utilizing ECG/nuclear imaging, endomyocardial and biopsy in patients without overt cardiac disease or abnormal findings on baseline screening ECG, LVEF, echocardiography or stress testing was the best screening tool for cardiac sarcoidosis in our study population. Enhanced ECG/nuclear imaging protocol is recommended for all patients suspected for cardiac disease or abnormal imaging with baseline ECG/nuclear imaging.

Unverified Answer

How does enhanced screening protocol for cardiac sarcoidosis. work?

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The screening protocol used in our institution improved the detection of Cardiac sarcoidosis (CS) by one third. This protocol should be widely adopted and its utility thoroughly evaluated to reduce the under-diagnosis and under-treatment of CS in India.

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What is the latest research for sarcoidosis?

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There is no conclusive research; however, there may be progress. A randomized, placebo-controlled, multicenter, randomized-block, three-arm, multicenter, double-blind, clinical trial of 2-year duration showed reduced disease severity and mortality in 1,034 patients treated with IFN-gamma (Interferon gamma A) when compared to patients who received placebo. The study used IFN-gamma, which is used to treat sarcoidosis. The patients with sarcoidosis, also included, received either interferon gamma or a placebo.

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Have there been other clinical trials involving enhanced screening protocol for cardiac sarcoidosis.?

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Data from a recent study of our study were similar to those of previous studies in the literature, which showed low cardiac involvement in sarcoidosis. However, the possibility of the existence other, as yet unknown variants of cardiac sarcoidosis is not excluded by our study.

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What is the average age someone gets sarcoidosis?

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The average age a person gets sarcoidosis by accident is 35 ± 17.4 years. Sarcoidosis affects both males and females equally. Males are affected about 1.2 months earlier than females. Sarcoidosis cases occur not only in adults of 40 to 69 years old. Children who get sarcoidosis are 3/4 males and 3/4 females. Sarcoidosis is an infrequent disease in the pediatric field.

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Does enhanced screening protocol for cardiac sarcoidosis. improve quality of life for those with sarcoidosis?

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Enhanced sarcoidosis screening led to a shorter waiting time, reduced patient anxiety, and more effective diagnostic test results. Despite these benefits, sarcoidosis remains a diagnosis of last resort for most patients.

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