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Global CMR Registry (GCMR)

17. juni 2016 oppdatert av: Society for Cardiovascular Magnetic Resonance

Global Cardiovascular Magnetic Resonance Registry

The Global CMR Registry aims to promote collaboration of CMR sites worldwide in setting imaging and reporting standards, assessing its diagnostic impact on patient care, and determining the cost-effectiveness of CMR imaging. It will be 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 called for. It will also be able to reflect any changes in patient impact from CMR over time as technical development evolves. Furthermore, it will allow an assessment of improvements in diagnostic and therapeutic thinking, risk stratification, and cost-effectiveness relevant to current patient management.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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:

  1. Variations in CMR protocols within specific clinical indications
  2. Variations in CMR post-processing, analysis, and reporting
  3. Practice adherence to appropriateness criteria and guidelines
  4. Clinical effectiveness of CMR over a long period of clinical application and/or technological advance
  5. 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.

Studietype

Observasjonsmessig

Registrering (Forventet)

80000

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 89 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The registry data will be collected from patients of various clinical CMR sites that have agreed to contribute their data to the registry.

Beskrivelse

Inclusion Criteria:

  • Cardiovascular disease, underwent CMR, CT, or ECG

Exclusion Criteria:

  • Patients who are 90 years and older

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tidsperspektiver: Retrospektiv

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Cardiovascular Magnetic Resonance Imaging
Cardiovascular imaging techniques (other subsidiary techniques such as CT and ECG will also be followed)
Fremgangsmåte: Cardiovascular Magnetic Resonance Imaging

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality
Tidsramme: 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
Tidsramme: Through study completion, for each year
heart failure development or worsening of heart failure
Through study completion, for each year
Acute myocardial infarction
Tidsramme: Through study completion, for each year
Through study completion, for each year

Sekundære resultatmål

Resultatmål
Tidsramme
Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)
Tidsramme: Through study completion, for each year
Through study completion, for each year
Cardiac Intervention (pacemakers)
Tidsramme: Through study completion, for each year
Through study completion, for each year
Cardiac Intervention (cardiac surgery)
Tidsramme: Through study completion, for each year
Through study completion, for each year
Cardiac Intervention (coronary revascularization)
Tidsramme: Through study completion, for each year
Through study completion, for each year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Society for Cardiovascular Magnetic Resonance

Etterforskere

  • Studiestol: Raymond Y. Kwong, MD, MPH, Brigham and Women's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2014

Primær fullføring (Forventet)

1. desember 2020

Datoer for studieregistrering

Først innsendt

13. juni 2016

Først innsendt som oppfylte QC-kriteriene

17. juni 2016

Først lagt ut (Anslag)

20. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

20. juni 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juni 2016

Sist bekreftet

1. juni 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SCMR_GRANT_001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

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.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Cardiovascular Magnetic Resonance Imaging

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Morocco

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere