Global CMR Registry (GCMR)
Global Cardiovascular Magnetic Resonance Registry
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
A global CMR registry can be a crucial infrastructure of our CMR community that has many benefits. First, it is the largest collective body of evidence reflecting the current clinical applications in patient care, which healthcare payers and governing bodies alike can depend on when metrics such as testing appropriateness, common indications, and diagnostic effectiveness are needed. Second, it reflects any change in patient impact from CMR over time as technical developments evolve. Third, it allows an assessment for improvement of diagnostic and therapeutic evaluation, risk stratification, and cost-effectiveness analysis relevant to patient management.
Some practical questions that a global CMR registry may be able ot address include:
- Variations in CMR protocols within specific clinical indications
- Variations in CMR post-processing, analysis, and reporting
- Practice adherence to appropriateness criteria and guidelines
- Clinical effectiveness of CMR over a long period of clinical application and/or technological advance
- Differences in CMR utility across centers, regions, or countries
The data collection process will be a collective effort on part of specialized health professionals across various CMR sites worldwide. All of the data will be extracted from existing registries and databases. Health professionals in the U.S. and abroad will first upload patient data and images onto the registry/database that they currently use. Then if they choose to, they can transmit relevant patient de-identified data onto the global registry using a user-friendly web interface. CMR sites without a database will be invited to use CMR Cooperative or REDCAP. De-identified data (usually submitted in excel or CSV format) will be harmonized and uploaded to the registry website (www.gcmr-scmr.org), which is a firewall and password-protected database that resides at an IT vendor (Center for Systems Biology at Massachusetts General Hospital) in Boston, Massachusetts. The pooled data will be used for retrospective analysis/research approved by the GCMR steering committee and SCMR.
Tipo di studio
Iscrizione (Anticipato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Cardiovascular disease, underwent CMR, CT, or ECG
Exclusion Criteria:
- Patients who are 90 years and older
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Cardiovascular Magnetic Resonance Imaging
Cardiovascular imaging techniques (other subsidiary techniques such as CT and ECG will also be followed)
|
Cardiac magnetic resonance imaging (CMR) has emerged as both a remarkably powerful diagnostic and prognostic tool for the assessment of cardiovascular disease. The high spatial resolution of CMR and the ability to characterize soft tissue provides the opportunity for unique diagnostic assessment of a myriad of cardiac pathology, including ischemic heart disease (IHD), preoperative assessment, intra- cardiac mass and thrombus, pericardial disease, valvular heart disease, and cardiomyopathy evaluation. Between individual CMR programs, GCMR will offer information useful in assessing the differences in protocol, performance, and clinical adaptation by varying geographic regions, institutional environments, and expertise. Such an assessment is critical for uncovering possible reasons for disparities in performance and obtaining opportunities for advancement. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mortality
Lasso di tempo: Mortality will be tracked through study completion, for each year
|
death from various causes including cardiovascular death
|
Mortality will be tracked through study completion, for each year
|
|
Heart Failure
Lasso di tempo: Through study completion, for each year
|
heart failure development or worsening of heart failure
|
Through study completion, for each year
|
|
Acute myocardial infarction
Lasso di tempo: Through study completion, for each year
|
Through study completion, for each year
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)
Lasso di tempo: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (pacemakers)
Lasso di tempo: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (cardiac surgery)
Lasso di tempo: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (coronary revascularization)
Lasso di tempo: Through study completion, for each year
|
Through study completion, for each year
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Raymond Y. Kwong, MD, MPH, Brigham and Women's Hospital
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SCMR_GRANT_001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Participating sites will send relevant de-identified to the data management team for harmonization. The aggregate data will be used for retrospective analyses and research. Researchers requesting data access for either grant proposals or sub-studies will be required to submit a proposal to the GCMR steering committee (composed of various experts in the CMR community) for approval.
If approved, data access will be given to the researchers for a specific time period determined by the magnitude of the work involved, and only for the purposes of the grant proposal or sub-study.
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .