ClinicalTrials.gov record NCT06610019
Cardiovascular Multimodality Imaging Study
Risk Stratification of Ischemic and Non-ischemic Cardiomyopathies in Racial and Ethnic Minority Groups in the Bronx - Cardiovascular Multimodality Imaging Study
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This retrospective registry analyzes existing cardiac magnetic resonance (CMR) and other imaging studies to study causes and outcomes of ischemic and non‑ischemic cardiomyopathies. It focuses on a racially and ethnically diverse patient population and links imaging features to outcomes such as death, sudden cardiac death, hospitalizations, and arrhythmias over up to five years.
What it is studying. The study is testing whether advanced imaging markers from CMR and other cardiac imaging can identify the likely cause (etiology) of different ischemic and non‑ischemic cardiomyopathies and whether those imaging features are associated with outcomes (overall mortality, sudden cardiac death, heart‑failure hospitalizations, total hospitalizations, and arrhythmias) in a diverse group of patients. It also aims to measure the prevalence and characteristics of these cardiomyopathies and to develop risk‑stratification models using imaging markers.
What the researchers hope to learn. To describe how common different ischemic and non‑ischemic cardiomyopathies are in a diverse patient group; to characterize their imaging features on CMR; to identify imaging markers linked with outcomes; and to develop imaging‑based risk models.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective chart and imaging review: researchers will use already-performed CMR scans and medical-record data. There is no prospective component and no new tests, procedures, or study visits for participants. Outcomes (for example, death, arrhythmias, and hospitalizations) are assessed from the index CMR through chart review for up to five years after that imaging.
How the study is structured. A retrospective observational registry: researchers collect and analyze existing CMR studies and medical-record data from adults who already had CMR. There is no prospective component and no new tests or treatments are given. Outcomes are assessed from records for up to five years after the index CMR.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Fabry disease
This trial is also listed on this site under ATTRv amyloidosis and wild-type ATTR amyloidosis.
Important dates
- Study start
- May 1, 2023
- Primary completion
- December 2031 (estimated)
- Study completion
- December 2031 (estimated)
- Target enrollment
- 10000 participants (estimated)
- Last updated on registry
- Aug 10, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Montefiore Medical Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Annalisa Filtz, MD 📞 929-232-9798 ✉ afiltz@montefiore.org
Participating sites (1)
- Montefiore Health SystemRecruiting
The Bronx, New York, 10467 · United States
- Leandro Slipczuk, MD · 267-455-2717 · lslipczukb@montefiore.org
- Leandro Slipczuk, MD
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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