- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02806193
Global CMR Registry (GCMR)
Global Cardiovascular Magnetic Resonance Registry
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Cardiovascular disease, underwent CMR, CT, or ECG
Exclusion Criteria:
- Patients who are 90 years and older
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Perspektywy czasowe: Z mocą wsteczną
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mortality
Ramy czasowe: 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
Ramy czasowe: Through study completion, for each year
|
heart failure development or worsening of heart failure
|
Through study completion, for each year
|
|
Acute myocardial infarction
Ramy czasowe: Through study completion, for each year
|
Through study completion, for each year
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Cardiac Intervention (Implantable cardioverter-defibrillator or ICD)
Ramy czasowe: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (pacemakers)
Ramy czasowe: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (cardiac surgery)
Ramy czasowe: Through study completion, for each year
|
Through study completion, for each year
|
|
Cardiac Intervention (coronary revascularization)
Ramy czasowe: Through study completion, for each year
|
Through study completion, for each year
|
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Raymond Y. Kwong, MD, MPH, Brigham and Women's Hospital
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SCMR_GRANT_001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .