Clinical trial NCT06610019: Cardiovascular Multimodality Imaging Study
Official title: Risk Stratification of Ischemic and Non-ischemic Cardiomyopathies in Racial and Ethnic Minority Groups in the Bronx - Cardiovascular Multimodality Imaging Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-ischemic Cardiomyopathy
Cardiomyopathies
Hypertrophic Cardiomyopathy
Right Ventricular Arrhythmogenic Cardiomyopathy
Cardiac Amyloidosis
Anderson Fabry Disease
Sarcoidosis
Cancer Therapy-related Cardiac Dysfunction
Ventricular Arrythmia
Heart Failure
Keywords: Cardiovascular Mortalities
Cardiomagnetic Resonance (CMR) Imaging
Prospective
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who receive a CMR study within the Montefiore Health System.

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 e.g. 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.

Upon further review, the Einstein Institutional Review Board (IRB) has determined that this is an ongoing, retrospective registry. and that there is no prospective component.

Eligibility criteria: Inclusion Criteria:

* Any adult patient (18 years or older) referred for a cardiovascular magnetic resonance (CMR) imaging study in the Montefiore Health System

Exclusion Criteria:

* Any patient who does not meet above criteria

Primary outcomes:
measure: Mortality
timeFrame: From index CMR imaging to time of chart review, up to 5 years
measure: Sudden Cardiac Death
timeFrame: From index CMR imaging to time of chart review, up to 5 years
Secondary outcomes:
measure: Heart Failure Hospitalizations
timeFrame: From index CMR imaging to time of chart review, up to 5 years
measure: Total Hospitalizations
timeFrame: From index CMR imaging to time of chart review, up to 5 years
measure: Arrhythmias
timeFrame: From index CMR imaging to time of chart review, up to 5 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Health System
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Leandro Slipczuk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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