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Clinical Trials/NCT01149590
NCT01149590
Completed
Not Applicable

Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic

University of Edinburgh12 sites in 1 country4,138 target enrollmentNovember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Angina Pectoris
Sponsor
University of Edinburgh
Enrollment
4138
Locations
12
Primary Endpoint
Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease
Status
Completed
Last Updated
last year

Overview

Brief Summary

The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.

Detailed Description

Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
May 2015
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18 and ≤75 years of age
  • Attendance at the Rapid Access Chest Pain Clinic

Exclusion Criteria

  • Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
  • Severe renal failure (serum creatinine \>200 µmol/L or estimated glomerular filtration rate \<30 mL/min)
  • Previous recruitment to the trial
  • Major allergy to iodinated contrast agent
  • Unable to give informed consent
  • Known pregnancy
  • Acute coronary syndrome within 3 months

Outcomes

Primary Outcomes

Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease

Time Frame: 6 weeks

Secondary Outcomes

  • Symptoms(Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months)
  • Investigations(Baseline, 6 weeks, 6 months)
  • Diagnosis(Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months)
  • Treatment(Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months)
  • Long-term outcome(10 years)

Study Sites (12)

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