Coronary Assessment for Mortality Prediction

NCT02208648 | Completed

• 1 other identifier: 14/P/108
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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?

Conditions

Peri-operative Mortality; Coronary Artery Calcium

Keywords

coronary calcification; Computed Tomography; Coronary artery calcium; calcium scores; post-operative mortality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the use of the calcium scoring technique in contrast enhanced studies.

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Plymouth Hospital NHS Trust patients

You may qualify if:

• All adults ≥18yrs old
• Major abdominal surgery (See HRG Codes)
• Bowel Cancer
• Elective admission

You may not qualify if:

• \<18 yrs old
• No suitable matched patient
• No CT Chest available
• Emergency admission

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 16632153 BACKGROUND

Study Officials

• Carl Roobottom, MBChB(Hons)

  Plymouth Hospital NHS Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: October 31, 2014
• Primary Completion: November 11, 2018
• Study Completion: November 11, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

GB (1)