NCT02798705|RecruitingDMC
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Sponsor study identifier
observational
30
1 country
1
Study Start
April 11, 2016
Actual (reported)Primary Completion
April 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The aim of the study is to evaluate coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and proportion of overt microvascular disease, defined as depressed CFR as well as elevated IMR in patients with cardiac amyloidosis. The second objective of this study is to compare results of non-invasive test including serum light chain amount, Doppler echocardiography with 2D strain, and cardiac perfusion MRI. The third object of this study is to evaluate the association between physiologic indices and pathologically measured percent area involvement of interstitium.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 11, 2016
Actual (reported)June 9, 2016
Actual (reported)June 14, 2016
Actual (reported)April 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
all-cause mortality
Comparison of all-cause mortality in amyloidosis patients with or without microvascular disease
2 Years
Correlation between IMR and echocardiographic parameters
within 3 months of diagnosis
Correlation between IMR and serum biochemicalmarkers
within 3 months of diagnosis
Distribution of CFR or IMR according to pathologic severity of myocardial involvement
within 3 months of diagnosis
Comparison of CFR or IMR value in amyloidosis patient with or without relative perfusion defect in myocardial perfusion imaging (ex> adenosine-SPECT or perfusion MRI)
within 3 months of diagnosis
Comparison of CFR or IMR value in different type of amyloidosis (AL type, hereditary type, AA type, senile type)
within 3 months of diagnosis
Pathologically confirmed amyloidosis patients with suspected cardiac involvement undergoing coronary angiography for coronary disease evaluation
Samsung Medical Center
Seoul, South Korea
Choi KH, Lee JM, Kim SR, Kim D, Choi JO, Kim SJ, Kim K, Kim JS, Koo BK, Jeon ES. Prognostic Value of the Index of Microcirculatory Resistance Over Serum Biomarkers in Cardiac Amyloidosis. J Am Coll Cardiol. 2020 Feb 11;75(5):560-561. doi: 10.1016/j.jacc.2019.11.045. No abstract available.
Joo Myung Lee, MD, MPH, PhD
Samsung Medical Center
Eun-Seok Jeon, MD, PhD
Samsung Medical Center
First Submitted
June 9, 2016
First Posted
June 14, 2016
Study Start
April 11, 2016
Actual (reported)Primary Completion
April 2029
EstimatedPET/MR Imaging In Patients With Cardiac Amyloidosis
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 14, 2025
Record last verified: 2025-03
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
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Source: ClinicalTrials.gov.
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