Cardiovascular Multimodality Imaging Study

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

• Registration Number: NCT06610019
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	From index CMR imaging to time of chart review, up to 5 years	The number of patients who died from any cause will be summarized and reported using basic descriptive statistics.
Sudden Cardiac Death	From index CMR imaging to time of chart review, up to 5 years	The number of patients who died from any cardiovascular-specific mortality will be summarized and reported using basic descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
Heart Failure Hospitalizations	From index CMR imaging to time of chart review, up to 5 years	The number of patients hospitalized with a primary diagnosis of heart failure will be summarized and reported using basic descriptive statistics.
Total Hospitalizations	From index CMR imaging to time of chart review, up to 5 years	The number of patients hospitalized with any diagnosis will be summarized and reported using basic descriptive statistics.
Arrhythmias	From index CMR imaging to time of chart review, up to 5 years	The number of patients with a diagnosis of an arrhythmia will be summarized and reported using basic descriptive statistics.

Trial Locations

Locations (1)

Montefiore Health System; 🇺🇸 Bronx, New York, United States