Ignite Creation Date:
2024-05-06 @ 3:05 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02208648
Status:
COMPLETED
Last Update Posted:
2019-09-04
First Post:
2014-08-04
Brief Title:
Coronary Assessment for Mortality Prediction
Sponsor:
University Hospital Plymouth NHS Trust
Organization:
University Hospital Plymouth NHS Trust
Study Overview
Official Title:
Coronary Assessment for Mortality Prediction
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMP
Brief Summary:
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
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
Detailed Description:
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 wo cc F36 Large Intestinal Disorders 69 or w cc F37 Large Intestinal Disorders 70 wo 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 wo cc F46 General Abdominal Disorders 69 or w cc F47 General Abdominal Disorders 70 wo 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
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 wo cc F36 Large Intestinal Disorders 69 or w cc F37 Large Intestinal Disorders 70 wo 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 wo cc F46 General Abdominal Disorders 69 or w cc F47 General Abdominal Disorders 70 wo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None