Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610019
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Cardiovascular Multimodality Imaging Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Risk Stratification of Ischemic and Non-ischemic Cardiomyopathies in Racial and Ethnic Minority Groups in the Bronx - Cardiovascular Multimodality Imaging Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis There is increased risk for cardiovascular disease and higher propensity for cardiovascular related mortality among Black and non-Hispanic White patients Recently advanced cardiac imaging has become a vital tool in diagnosis and risk stratification of cardiovascular disease Very limited data is available on the prevalence and characteristics of different cardiovascular diseases in Hispanic and African American minority groups therefore studying different racial and ethnic minority groups in the Bronx population is an exceptionally valuable source to determine the prevalence of cardiomyopathies among minority groups along with study survival in this population This study aims to determine the etiology of cardiovascular disease in a diverse patient population by utilizing various cardiovascular imaging modalities with a focus on cardiac magnetic resonance CMR imaging and to develop risk stratification models by applying advanced cardiovascular imaging markers
Detailed Description:
Significant Hispanic and African American populations live in the Bronx and belong to the Montefiore Health System Based on literature data African Americans and Hispanics have a higher incidence of morbidity and mortality for various cardiovascular diseases CVD compared to non-Hispanic Whites More than 53 million Hispanics currently live in the United States which is 17 of the total US population and is expected to constitute 30 of the total US population by 2050 The increased risk for CVD is also well documented in the African American minority group Although limited data is available on the prevalence and characteristics of different cardiovascular diseases in these minority groups During the last two decades advanced cardiovascular imaging modalities such as cardiovascular magnetic resonance CMR imaging became trusted tools in the risk stratification of patients with ischemic and non-ischemic cardiomyopathies
Cardiovascular magnetic resonance CMR imaging is the gold standard for quantifying chamber size and function In addition to ejection fraction CMR feature-tracking CMR-FT is a new postprocessing technique that allows the assessment of myocardial mechanics from routinely acquired cine images without specialized additional pulse sequences Basic global longitudinal strain has been proved as a predictive marker in non-ischemic cardiomyopathy NICM CMR imaging can also provide tissue-specific information about the myocardium using specific techniques such as late gadolinium enhancement LGE or other quantitative parameters like T1 mapping both native and with measurement of extracellular volume fraction Based on this CMR imaging is an optimal modality to differentiate ischemic cardiomyopathy ICM and non-ischemic myocardial disease and diagnose different forms of NICM
NICM represents a heterogeneous group of patients with multiple underlying etiologies The pathogenesis of NICM with ventricular dilatation and reduced cardiac function in the absence of flow-limiting coronary artery disease CAD can be genetic inflammatory toxic or viral However in the vast majority of cases the origin is unclear NICM may be either primary eg Hypertrophic cardiomyopathy HCM Right ventricular Arrhythmogenic Cardiomyopathy ARVC or secondary to systemic diseases such as Cardiac amyloidosis CA Anderson-Fabry disease Sarcoidosis or even iatrogenic as Cancer therapy-related cardiac dysfunction CTRCD Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis
A similar unregistered study with the same study design is also being conducted in a retrospective patient cohort Einstein Institutional Review Board IRB Number 2022-14552 This registration is exclusive to the prospective cohort ID 2024-16138
Cardiovascular magnetic resonance CMR imaging is the gold standard for quantifying chamber size and function In addition to ejection fraction CMR feature-tracking CMR-FT is a new postprocessing technique that allows the assessment of myocardial mechanics from routinely acquired cine images without specialized additional pulse sequences Basic global longitudinal strain has been proved as a predictive marker in non-ischemic cardiomyopathy NICM CMR imaging can also provide tissue-specific information about the myocardium using specific techniques such as late gadolinium enhancement LGE or other quantitative parameters like T1 mapping both native and with measurement of extracellular volume fraction Based on this CMR imaging is an optimal modality to differentiate ischemic cardiomyopathy ICM and non-ischemic myocardial disease and diagnose different forms of NICM
NICM represents a heterogeneous group of patients with multiple underlying etiologies The pathogenesis of NICM with ventricular dilatation and reduced cardiac function in the absence of flow-limiting coronary artery disease CAD can be genetic inflammatory toxic or viral However in the vast majority of cases the origin is unclear NICM may be either primary eg Hypertrophic cardiomyopathy HCM Right ventricular Arrhythmogenic Cardiomyopathy ARVC or secondary to systemic diseases such as Cardiac amyloidosis CA Anderson-Fabry disease Sarcoidosis or even iatrogenic as Cancer therapy-related cardiac dysfunction CTRCD Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis
A similar unregistered study with the same study design is also being conducted in a retrospective patient cohort Einstein Institutional Review Board IRB Number 2022-14552 This registration is exclusive to the prospective cohort ID 2024-16138
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None