CMR for CA: Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis
Study Details
Study Description
Brief Summary
The study aims to test the diagnostic accuracy of native T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that native T1 mapping with a cut-off value of 1341ms (3 tesla CMR) in older patients with symptomatic heart failure, increased LV wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (CA).
As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Cardiac amyloidosis (CA) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. The prevalence of CA among patients with heart failure and left ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging because specific clinical signs are often lacking.
Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1 values on cardiac magnetic resonance (CMR). Therefore, native T1 imaging provides a promising non-invasive method to identify CA.
A preliminary retrospective analysis of 128 patients with increased LV wall thickness identified an area under the curve of 0.9954 (p<0.0001) for native T1 to detect CA. The optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%.
The investigators aim to test the diagnostic accuracy of native T1 mapping with the threshold of 1341ms for the diagnosis of CA compared to the reference method prospectively. Moreover, the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Native T1 CMR Diagnostic accuracy of native T1 CMR and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive) |
Diagnostic Test: Native T1 CMR
Observed method
Diagnostic Test: Web-based ATTR probability estimator (Pfizer, New York)
Observed method
Diagnostic Test: 99mTc-DPD scintigraphy
Reference method
Diagnostic Test: Laboratory screening for multiple myeloma / AL amyloidosis
Reference method
Procedure: Cardiac biopsy
If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
|
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy of native T1 LV mapping for diagnosis of CA [up to 7 days]
Comparison native T1 CMR with the reference method for diagnosis of CA
Secondary Outcome Measures
- Diagnostic accuracy of ATTR probability estimator to predict CA [up to 7 days]
Comparison of a probability score to predict ATTR with the final diagnosis of ATTR
- Association of native T1 values with cardiovascular outcome [1 years]
All-cause death, cardiovascular death and heart failure hospitalizations
- Association of ATTR probability estimator values with cardiovascular outcome [1 year]
All-cause death, cardiovascular death and heart failure hospitalizations
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 60 years
-
Symptomatic heart failure (NYHA II-IV) with LVEF ≥40%
-
Increased LV wall thickness (≥12mm end-diastolic)
-
NT-proBNP ≥1000pg/mL
-
Elevated hs-troponin T ≥14ng/L
Exclusion Criteria:
-
Contraindications for CMR
-
Acute myocarditis
-
Acute myocardial infarction <1 month
-
Severe aortic stenosis and RAISE score < 2 points
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Leipzig | Leipzig | Saxony | Germany | 04103 |
Sponsors and Collaborators
- University of Leipzig
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DL-L-20006_V16