- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02208648
Coronary Assessment for Mortality Prediction (CAMP)
The study will investigate whether the presence of coronary artery calcium as demonstrated on pre-operative, thoracic staging Computed Tomography (CT) is an independent risk factor for 90 day mortality in patients undergoing major abdominal surgery.
The study research question: Do higher levels of coronary calcification correlate to an increased risk of post-operative mortality in patients undergoing major abdominal surgery?
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The study uses a retrospective observational study design.
Due to the nature of the subject of the study and its retrospective design no patient contact will be necessary and all imaging reviewed will have been acquired as part of their routine level of care.
Plan for the gathering of study data
A list of patients with the following surgical codes will be identified from the hospital surgical performance database to create retrospective dataset of 5 years' worth of cases (to December 2013). This date range may be extended to ensure an adequate sample size. :
Surgical codes (Healthcare Resource Groups (HRG) codes) to be included:
F31 Large Intestine - Complex Procedures F32 Large Intestine - Very Major Procedures F33 Large Intestine - Major Procedures with complications and comorbidities (w cc) F34 Large Intestine - Major Procedures without complications and comorbidities (w/o cc) F36 Large Intestinal Disorders >69 or w cc F37 Large Intestinal Disorders <70 w/o cc
F41 General Abdominal - Very Major or Major Procedures patients over 69 years of age (>69) or w cc F42 General Abdominal - Very Major or Major Procedures patients under 70 years of age (<70) w/o cc F46 General Abdominal Disorders >69 or w cc F47 General Abdominal Disorders <70 w/o cc
Cross-reference with Somerset Cancer Register and remove any who were not recognised as having bowel cancer.
This patient list will be cross-referenced with records of peri-operative mortality (within 90 days)
Propensity match each deceased patient to a patient who survived beyond 90 days. Our matching rules will be in descending order of importance :
- HRG code
- gender,
- cancer staging
- Age+/-5yrs.
- American Society of Anesthesiologists (ASA) Grade
Where there are multiple potential matches then this will be resolved by consultation between the research team members.
Pairs of CT scans (deceased plus matched control) will be procured from WebPACS (Web Picture Archival Communication System).
Scans will be anonymised and stored on a dedicated secure radiology research server.
Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using the calcium scoring method. Calcium burden will be recorded on a scale of 1-12 . The radiologist will be blinded to the group that the patient belongs to, to minimise bias.
Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs. Radiologist (s) will be blinded to group allocation. Scans will not be "paired" at the time of reading.
Interim statistical analysis (of calcium scores) will be performed after each batch of scans.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
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Devon
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Plymouth, Devon, Regno Unito, PL6 8DH
- Plymouth Hospitals NHS Trust
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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:
- All adults ≥18yrs old
- Major abdominal surgery (See HRG Codes)
- Bowel Cancer
- Elective admission
Exclusion Criteria:
- <18 yrs old
- No suitable matched patient
- No CT Chest available
- Emergency admission
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Deceased
Peri-operative mortality (within 90 days).
Pairs of CT scans (deceased plus matched control) will be anonymised and stored on a secure server.
Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using a calcium scoring method.
The radiologist will be blinded to the group that the patient belongs to, to minimise bias.
Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs.
Radiologist (s) will be blinded to group allocation.
Scans will not be "paired" at the time of reading.
|
|
Matched control
Patients who survived beyond 90 days peri-operatively.
Pairs of CT scans (deceased plus matched control) will be anonymised and stored on a secure server.
Abbreviated Calcium scores will be generated for all patients in the trial by a trained radiologist using a calcium scoring method.
The radiologist will be blinded to the group that the patient belongs to, to minimise bias.
Scans (deceased patients and matched controls) will be analysed in batches of 30 pairs.
Radiologist (s) will be blinded to group allocation.
Scans will not be "paired" at the time of reading.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The primary outcome measure is an abbreviated calcium score
Lasso di tempo: 5 years
|
To investigate whether the presence and severity of coronary calcification identified on routine, pre-operative staging CT scans of the chest are an independent risk factor for patients undergoing major surgery.
Techniques have now been validated where calcium scores can be estimated from routine CT scans of the chest (Shemesh et al. 2006).
|
5 years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
To assess the use of the calcium scoring technique in contrast enhanced studies.
Lasso di tempo: 5 years
|
5 years
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Carl Roobottom, MBChB(Hons), Plymouth Hospital NHS Trust
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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 (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 14/P/108
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 .
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