- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02806193
Global CMR Registry (GCMR)
Global Cardiovascular Magnetic Resonance Registry
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Cardiovascular disease, underwent CMR, CT, or ECG
Exclusion Criteria:
- Patients who are 90 years and older
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Aikanäkymät: Takautuva
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mortality
Aikaikkuna: 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
Aikaikkuna: Through study completion, for each year
|
heart failure development or worsening of heart failure
|
Through study completion, for each year
|
|
Acute myocardial infarction
Aikaikkuna: Through study completion, for each year
|
Through study completion, for each year
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
|
Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)
Aikaikkuna: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (pacemakers)
Aikaikkuna: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (cardiac surgery)
Aikaikkuna: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (coronary revascularization)
Aikaikkuna: Through study completion, for each year
|
Through study completion, for each year
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Opintojen puheenjohtaja: Raymond Y. Kwong, MD, MPH, Brigham and Women's Hospital
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SCMR_GRANT_001
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
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