Screening for Cardiac Amyloidosis Using Nuclear Imaging for Minority Populations (SCAN-MP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03812172|
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : February 20, 2020
|Condition or disease||Intervention/treatment|
|Amyloid Cardiomyopathy, Transthyretin-Related||Drug: 99mTc-PYP|
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|Official Title:||Screening for Cardiac Amyloidosis Using Nuclear Cardiology for Minority Populations|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
Blacks/Hispanics with Heart Failure
Blacks/Hispanics with heart failure due to transthyretin cardiac amyloidosis will be identified by 99mTc-PYP scintigraphy. Those with transthyretin cardiac amyloidosis will be further subtyped into those with a genetic cause (ATTRm) and those with a non-genetic cause (ATTRwt - wild type transthyretin cardiac amyloidosis).
10 mCi of 99mTc-PYP will be administered intravenously and imaging will be performed after 1 hour.
Other Name: Technetium-99m-Pyrophosphate
- Prevalence of Transthyretin Cardiac Amyloidosis in Caribbean Hispanics and Blacks with heart failure (HF) [ Time Frame: 5 years ]The prevalence of ATTR CA will be defined by the number of cases with significant myocardial retention of Tc-99 PYP including both ATTRwt and ATTRm CA as a percentage of total enrollment.
- Prevalence of ATTRwt and ATTRm in Blacks and Caribbean Hispanics [ Time Frame: 5 years ]Among subjects with ATTR-CA we will determine the prevalence of ATTRwt and ATTRm from the Val122Ile mutation in Blacks and Caribbean Hispanics
- Sex distribution of ATTR cardiac amyloidosis [ Time Frame: 5 years ]The prevalence of ATTR cardiac amyloidosis will be calculated among men and women enrolled in this study
- Disease progression in ATTRwt compared to ATTRm [ Time Frame: 5 years ]In the ATTR CA group alone, a composite time-to-first-event endpoint at 1-year of death, heart failure hospitalization, or 30% decline in 6-minute hall walk will be compared between ATTRwt and ATTRm subjects.
- RBP4 in Urine [ Time Frame: 5 years ]Retinol binding protein 4 (RBB4) will be measured in urine.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812172
|Contact: Stephen Helmkefirstname.lastname@example.org|
|Contact: Mathew S. Maurer, MDemail@example.com|
|United States, Massachusetts|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Contact: Denise Fine 617-638-8716|
|Principal Investigator: Frederick L. Ruberg, MD|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Stephen Helmke, RDCS MPH 212-932-4537 firstname.lastname@example.org|
|Principal Investigator: Mathew S. Maurer, MD|
|New York, New York, United States, 10037|
|Contact: Damian C. Kurian, MD 212-939-4701 email@example.com|
|Contact: Ivrose Janvier, PA 212-939-4700 Ivrose.Janvier@nychcc.org|
|Principal Investigator: Damian C. Kurian, MD|
|Principal Investigator:||Mathew S. Maurer, MD||Columbia University|
|Principal Investigator:||Frederick L Ruberg, MD||Boston Medical Center/Boston University Medical Center|