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Early Screening using Enhanced ECG analysis for Cardiac Sarcoidosis in Adults with known Extra-cardiac Sarcoidosis.

Early Screening using Enhanced ECG analysis for Cardiac Sarcoidosis in Adults

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000535370
Acronym
ESCaS Study
Enrollment
12
Registered
2026-04-30
Start date
2026-07-23
Completion date
2027-08-30
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The ESCaS Study is an observational diagnostic accuracy pilot investigating whether enhanced ECG analysis can detect early cardiac involvement in patients with confirmed extra-cardiac sarcoidosis. Participants attend a single study visit for a standardised clinical assessment, routine 12-lead ECG, blood biomarker sampling, validated health questionnaires, and CMR. Enhanced ECG analysis is performed offline using established computational algorithms and compared with CMR, the reference standard, to evaluate diagnostic performance. Additional analyses include correlations between ECG features, advanced CMR modelling, and both routine and exploratory blood biomarkers such as sIL-2R. This multimodality approach aims to improve early screening strategies for cardiac sarcoidosis by integrating electrical, structural, and biological indicators of disease.

Interventions

This study is an observational diagnostic accuracy investigation evaluating the utility of enhanced electrocardiogram (ECG) analysis for detecting cardiac involvement in individuals with established extra-cardiac sarcoidosis. All participants will attend a single study visit during which they will undergo a standardised clinical assessment. The overall duration of the clinic visit will be up to 3 hours. This visit includes: (1) Clinical review & physical assessment - 15 minutes (2) Routine 1

This study is an observational diagnostic accuracy investigation evaluating the utility of enhanced electrocardiogram (ECG) analysis for detecting cardiac involvement in individuals with established extra-cardiac sarcoidosis. All participants will attend a single study visit during which they will undergo a standardised clinical assessment. The overall duration of the clinic visit will be up to 3 hours. This visit includes: (1) Clinical review & physical assessment - 15 minutes (2) Routine 12-lead ECG - 15 minutes (3) Blood sampling for both routine cardiac biomarkers and exploratory inflammatory markers - 15 minutes (3) Completion of validated health questionnaires (SF-36, King's Sarcoidosis Questionnaire) - 30 minutes (4) Cardiac magnetic resonance (CMR) scan, which serves as the reference standard for determining cardiac involvement - 1 hour Enhanced ECG analysis will be performed offline using established computational platforms, including Advanced-ECG and the GE Healthcare Marquette 12SL algorithm. These analyses will be applied to the digital ECG files obtained during the study visit and will not require any additional testing or participant involvement. Enhanced ECG-derived electrical parameters will subsequently be compared with CMR findings to determine their diagnostic performance in identifying early or subclinical cardiac involvement. All participants will undergo a comprehensive CMR scan that includes standard clinical sequences as well as research-specific sequences. Imaging will be reviewed by trained cardiologists and further processed using externally validated computational tools developed by the Auckland Bioengineering Institute. Overall, this multimodality observational pilot study integrates clinical data, ECG analysis, blood biomarkers, and advanced CMR imaging to assess whether enhanced ECG analysis can improve early detection and screening strategies for cardiac sarcoidosis.

This study will evaluate the utility of enhanced electrocardiogram (ECG) analysis for detecting cardiac involvement in individuals with established extra-cardiac sarcoidosis. All participants will attend a single study visit during which they will undergo a standardised clinical assessment. The overall duration of the clinic visit will be up to 3 hours. This visit includes: (1) Clinical review & physical assessment - 15 minutes (2) Routine 12-lead ECG - 15 minutes (3) Blood sampling for bot

This study will evaluate the utility of enhanced electrocardiogram (ECG) analysis for detecting cardiac involvement in individuals with established extra-cardiac sarcoidosis. All participants will attend a single study visit during which they will undergo a standardised clinical assessment. The overall duration of the clinic visit will be up to 3 hours. This visit includes: (1) Clinical review & physical assessment - 15 minutes (2) Routine 12-lead ECG - 15 minutes (3) Blood sampling for both routine cardiac biomarkers and exploratory inflammatory markers - 15 minutes (3) Completion of validated health questionnaires (SF-36, King's Sarcoidosis Questionnaire) - 30 minutes (4) Cardiac magnetic resonance (CMR) scan, which serves as the reference standard for determining cardiac involvement - 1 hour Enhanced ECG analysis will be performed offline using established computational platforms, including Advanced-ECG and the GE Healthcare Marquette 12SL algorithm. These analyses will be applied to the digital ECG files obtained during the study visit and will not require any additional testing or participant involvement. These E-ECG–derived indices will be compared with cardiac MRI findings, including the presence or absence of LGE and extracellular volume, to assess their relationship with subclinical cardiac involvement. This is a multivariable model development study of E-ECG parameters that can identify CMR defined subclinical cardiac involvement. All participants will undergo a comprehensive CMR scan that includes standard clinical sequences as well as research-specific sequences. Imaging will be reviewed by trained cardiologists and further processed using externally validated computational tools developed by the Auckland Bioengineering Institute. Overall, this multimodality observational study integrates clinical data, ECG analysis, blood biomarkers, and advanced CMR imaging to assess whether enhanced ECG analysis can improve early detection and screening strategies for cardiac sarcoidosis.

Sponsors

Auckland City Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1) Adults aged 18 years or older 2) Extra-cardiac sarcoidosis will be defined according to international American Thoracic Society / European Respiratory Society / World Association of Sarcoidosis and Other Granulomatous Disorders (ATS/ERS/WASOG) diagnostic criteria 3) Able to provide informed consent.

Exclusion criteria

1) Patient has known cardiac sarcoidosis 2) Patient has a contraindication to cardiac magnetic resonance (CMR) imaging or is unlikely to tolerate due to severe claustrophobia. 3) The patient has an abnormal electrocardiogram (ECG) related to a known cardiac disease such as hypertrophic cardiomyopathy or prior myocardial infarction (evidenced by pathological Q waves in 2 or more contiguous leads e.g., greater or equal to 30 ms or greater or equal to 0.1 mV) which could confound ECG/CMR interpretation

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026