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?

Study Overview

• Status: Completed
• Conditions: Peri-operative Mortality; Coronary Artery Calcium

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 (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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Plymouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Plymouth Hospital NHS Trust patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome measure is an abbreviated calcium score	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

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the use of the calcium scoring technique in contrast enhanced studies.	5 years

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Study Chair: Carl Roobottom, MBChB(Hons), Plymouth Hospital NHS Trust

Publications and helpful links

General Publications

• Shemesh J, Henschke CI, Farooqi A, Yip R, Yankelevitz DF, Shaham D, Miettinen OS. Frequency of coronary artery calcification on low-dose computed tomography screening for lung cancer. Clin Imaging. 2006 May-Jun;30(3):181-5. doi: 10.1016/j.clinimag.2005.11.002.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2014
• Primary Completion (Actual): November 11, 2018
• Study Completion (Actual): November 11, 2018

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Computed Tomography; coronary calcification; Coronary artery calcium; calcium scores; post-operative mortality
• Other Study ID Numbers: 14/P/108