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

Overview

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.

Primary outcome measures

• Mortality [Time frame: From index CMR imaging to time of chart review, up to 5 years]
• Sudden Cardiac Death [Time frame: From index CMR imaging to time of chart review, up to 5 years]

Secondary outcome measures (3)

• Heart Failure Hospitalizations [Time frame: From index CMR imaging to time of chart review, up to 5 years]
• Total Hospitalizations [Time frame: From index CMR imaging to time of chart review, up to 5 years]
• Arrhythmias [Time frame: From index CMR imaging to time of chart review, up to 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Montefiore Health System — The Bronx

Publications

• Rodriguez CJ, Allison M, Daviglus ML, Isasi CR, Keller C, Leira EC, Palaniappan L, Pina IL, Ramirez SM, Rodriguez B, Sims M; American Heart Association Council on Epidemiology and Prevention; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular and Stroke Nursing. Status of cardiovascular disease and stroke in Hispanics/Latinos in the Unit PMID 25098323
• Daviglus ML, Talavera GA, Aviles-Santa ML, Allison M, Cai J, Criqui MH, Gellman M, Giachello AL, Gouskova N, Kaplan RC, LaVange L, Penedo F, Perreira K, Pirzada A, Schneiderman N, Wassertheil-Smoller S, Sorlie PD, Stamler J. Prevalence of major cardiovascular risk factors and cardiovascular diseases among Hispanic/Latino individuals of diverse backgrounds in the United States. JAMA. 2012 Nov 7;308 PMID 23117778
• Barber S, Hickson DA, Wang X, Sims M, Nelson C, Diez-Roux AV. Neighborhood Disadvantage, Poor Social Conditions, and Cardiovascular Disease Incidence Among African American Adults in the Jackson Heart Study. Am J Public Health. 2016 Dec;106(12):2219-2226. doi: 10.2105/AJPH.2016.303471. Epub 2016 Oct 13. PMID 27736207
• Carnethon MR, Pu J, Howard G, Albert MA, Anderson CAM, Bertoni AG, Mujahid MS, Palaniappan L, Taylor HA Jr, Willis M, Yancy CW; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; and Stroke Council. C PMID 29061565
• Hozawa A, Folsom AR, Sharrett AR, Chambless LE. Absolute and attributable risks of cardiovascular disease incidence in relation to optimal and borderline risk factors: comparison of African American with white subjects--Atherosclerosis Risk in Communities Study. Arch Intern Med. 2007 Mar 26;167(6):573-9. doi: 10.1001/archinte.167.6.573. PMID 17389288
• Patel AR, Kramer CM. Role of Cardiac Magnetic Resonance in the Diagnosis and Prognosis of Nonischemic Cardiomyopathy. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1180-1193. doi: 10.1016/j.jcmg.2017.08.005. PMID 28982571
• Leiner T, Bogaert J, Friedrich MG, Mohiaddin R, Muthurangu V, Myerson S, Powell AJ, Raman SV, Pennell DJ. SCMR Position Paper (2020) on clinical indications for cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2020 Nov 9;22(1):76. doi: 10.1186/s12968-020-00682-4. PMID 33161900
• Romano S, Judd RM, Kim RJ, Heitner JF, Shah DJ, Shenoy C, Evans K, Romer B, Salazar P, Farzaneh-Far A. Feature-Tracking Global Longitudinal Strain Predicts Mortality in Patients With Preserved Ejection Fraction: A Multicenter Study. JACC Cardiovasc Imaging. 2020 Apr;13(4):940-947. doi: 10.1016/j.jcmg.2019.10.004. Epub 2019 Nov 11. PMID 31727563

Identifiers

NCT: NCT06610019 · 2022-14552

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗