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NCT Number: NCT06610019

Cardiovascular Multimodality Imaging Study

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.

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Key information

Conditions

Non-ischemic Cardiomyopathy Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis, Familial Anderson Fabry Disease Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmogenic Right Ventricular Dysplasia Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cancer Therapy-related Cardiac Dysfunction Cardiac Amyloidosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fabry Disease Genetic Diseases, Inborn Genetic Diseases, X-Linked Heart Defects, Congenital Heart Diseases Heart Failure Heart Valve Diseases Hemic and Lymphatic Diseases Heredodegenerative Disorders, Nervous System Hypersensitivity Hypersensitivity, Delayed Hypertrophic Cardiomyopathy Immune System Diseases Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lymphatic Diseases Lymphoproliferative Disorders Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Proteostasis Deficiencies Right Ventricular Arrhythmogenic Cardiomyopathy Sarcoidosis Sphingolipidoses Vascular Diseases Ventricular Arrythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Health System

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Leandro Slipczuk, MD

CONTACT

[email protected]

267-455-2717

Leandro Slipczuk, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 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.

  2. Sudden Cardiac Death

    Time frame: 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 outcomes

  1. Heart Failure Hospitalizations

    Time frame: 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.

  2. Total Hospitalizations

    Time frame: 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.

  3. Arrhythmias

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Park, MD

CONTACT

[email protected]

678-451-6247

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Risk Stratification of Ischemic and Non-ischemic Cardiomyopathies in Racial and Ethnic Minority Groups in the Bronx - Cardiovascular Multimodality Imaging Study

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Sep 24, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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