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RecruitingNCT06610019Updated Aug 10, 2026

Cardiovascular Multimodality Imaging Study

An observational study in Non-ischemic Cardiomyopathy, Cardiomyopathies and Hypertrophic Cardiomyopathy, sponsored by Montefiore Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Montefiore Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All adult patients who receive a CMR study within the Montefiore Health System.

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

Exclusion Criteria:

  • Any patient who does not meet above criteria
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Mortality

    The number of patients who died from any cause will be summarized and reported using basic descriptive statistics.

    Time frame: From index CMR imaging to time of chart review, up to 5 years

  2. Sudden Cardiac Death

    The number of patients who died from any cardiovascular-specific mortality will be summarized and reported using basic descriptive statistics.

    Time frame: From index CMR imaging to time of chart review, up to 5 years

Secondary outcomes

  1. Heart Failure Hospitalizations

    The number of patients hospitalized with a primary diagnosis of heart failure will be summarized and reported using basic descriptive statistics.

    Time frame: From index CMR imaging to time of chart review, up to 5 years

  2. Total Hospitalizations

    The number of patients hospitalized with any diagnosis will be summarized and reported using basic descriptive statistics.

    Time frame: From index CMR imaging to time of chart review, up to 5 years

  3. Arrhythmias

    The number of patients with a diagnosis of an arrhythmia will be summarized and reported using basic descriptive statistics.

    Time frame: From index CMR imaging to time of chart review, up to 5 years

06

Study locations

1 of 1 sites recruiting
  • Montefiore Health System
    The Bronx, New York 10467, United States
    Recruiting
07

References and documents

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 United States: a science advisory from the American Heart Association. Circulation. 2014 Aug 12;130(7):593-625. doi: 10.1161/CIR.0000000000000071. Epub 2014 Jul 14. PubMed 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(17):1775-84. doi: 10.1001/jama.2012.14517. PubMed 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. PubMed 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. Cardiovascular Health in African Americans: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 21;136(21):e393-e423. doi: 10.1161/CIR.0000000000000534. Epub 2017 Oct 23. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 31727563 ↗
  • Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Hinojar R, Doltra A, Varma N, Child N, Rogers T, Suna G, Arroyo Ucar E, Goodman B, Khan S, Dabir D, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. T1-Mapping and Outcome in Nonischemic Cardiomyopathy: All-Cause Mortality and Heart Failure. JACC Cardiovasc Imaging. 2016 Jan;9(1):40-50. doi: 10.1016/j.jcmg.2015.12.001. PubMed 26762873 ↗
  • Kuruvilla S, Adenaw N, Katwal AB, Lipinski MJ, Kramer CM, Salerno M. Late gadolinium enhancement on cardiac magnetic resonance predicts adverse cardiovascular outcomes in nonischemic cardiomyopathy: a systematic review and meta-analysis. Circ Cardiovasc Imaging. 2014 Mar;7(2):250-258. doi: 10.1161/CIRCIMAGING.113.001144. Epub 2013 Dec 20. PubMed 24363358 ↗
  • Elliott P, Andersson B, Arbustini E, Bilinska Z, Cecchi F, Charron P, Dubourg O, Kuhl U, Maisch B, McKenna WJ, Monserrat L, Pankuweit S, Rapezzi C, Seferovic P, Tavazzi L, Keren A. Classification of the cardiomyopathies: a position statement from the European Society Of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2008 Jan;29(2):270-6. doi: 10.1093/eurheartj/ehm342. Epub 2007 Oct 4. PubMed 17916581 ↗
  • Maron BJ, Towbin JA, Thiene G, Antzelevitch C, Corrado D, Arnett D, Moss AJ, Seidman CE, Young JB; American Heart Association; Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; Council on Epidemiology and Prevention. Contemporary definitions and classification of the cardiomyopathies: an American Heart Association Scientific Statement from the Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; and Council on Epidemiology and Prevention. Circulation. 2006 Apr 11;113(14):1807-16. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27. PubMed 16567565 ↗
  • Rapezzi C, Arbustini E, Caforio AL, Charron P, Gimeno-Blanes J, Helio T, Linhart A, Mogensen J, Pinto Y, Ristic A, Seggewiss H, Sinagra G, Tavazzi L, Elliott PM. Diagnostic work-up in cardiomyopathies: bridging the gap between clinical phenotypes and final diagnosis. A position statement from the ESC Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 May;34(19):1448-58. doi: 10.1093/eurheartj/ehs397. Epub 2012 Dec 4. PubMed 23211230 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06610019
Lead sponsor
Montefiore Medical Center
Responsible party
Sponsor
First posted
Sep 24, 2024
Start date
May 1, 2023
Primary completion
Dec 2031 (estimated)
Completion
Dec 2031 (estimated)
Last update
Aug 10, 2026

Study contacts

Annalisa Filtz, MD
Contact
afiltz@montefiore.org
929-232-9798
Leandro Slipczuk, MD, PhD
principal investigator · Montefiore Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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