NCT01660594

Brief Summary

Patients with stable chest pain presenting to general practitioners in UK are routinely referred to the chest pain clinics in the hospitals. They are assessed by clinical history including risk factors, cardiovascular exam, resting ECG, chest x-ray, and exercise ECG. CT calcium scoring (CTCS) is a technique that is very sensitive in identifying and quantifying calcified atherosclerotic plaques. Recent guidance from the National Institute of Clinical Excellence (NICE, citation 1) proposes the use of CTCS in patients with stable chest pain who have low likelihood of coronary artery disease (CAD). They recommend that patients with low likelihood (10-30%) have a CTCS and if the score is 0, they can be considered to have non-cardiac chest pain. However, there is controversy regarding relationship of absent calcification with significant CAD and its prognostic value. At our institution, we have been performing CTCS in this patient cohort since 2003. We plan to retrospectively review the usefulness in CTCS in patients with different likelihood for significant CAD, particularly in patients with absent calcium and compare with the traditional assessment. We also plan to follow-up these patients for any myocardial infarction and death from any cause.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
705

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

August 6, 2012

Last Update Submit

August 8, 2012

Conditions

Keywords

coronary diseasetomography, x-ray computedcalciumexercise test

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    7 years

Secondary Outcomes (1)

  • Non-fatal myocardial infarction

    7 years

Other Outcomes (1)

  • Obstructed coronary artery disease

    3 months

Study Arms (1)

Stable chest pain

All patients presenting with stable chest pain and referred by their general practitioners to the chest pain clinic in the hospital who had CT calcium scoring performed besides standard assessment.

Other: CT calcium scoring

Interventions

CT Calcium scoring was performed in the patients as an imaging test in addition to the traditional assessment on the same day of patients attending the chest pain clinic on the first visit. This was performed with standard protocol and the absolute calcium score was calculated.

Stable chest pain

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who presented to our chest pain clinic between October 2003 to March 2010 with stable (non-acute) chest pain and assessed with history, physical examination, cardiovascular risk factors, chest X-ray, 12-lead resting ECG and exercise ECG.

You may qualify if:

  • non-acute chest pain
  • those who underwent CT calcium scoring
  • availability of all relevant risk factor information

You may not qualify if:

  • previous coronary disease i.e., myocardial infarction or revascularization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harefield Hospital

London, Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (1)

  • Skinner JS, Smeeth L, Kendall JM, Adams PC, Timmis A; Chest Pain Guideline Development Group. NICE guidance. Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin. Heart. 2010 Jun;96(12):974-8. doi: 10.1136/hrt.2009.190066. No abstract available.

    PMID: 20538674BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

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

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

June 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations