Coronary Artery DiseaseNCT03168269
Can CCTA Technicians Provide Accurate Interpretation of Findings in Patients Presenting to the ED in After Hours?
An observational study of Coronary Artery Disease, run by Jordan Collaborating Cardiology Group.
Trial summary
Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice in chest pain patients with low to intermediate probability of coronary artery disease (CAD). Qualified CCTA readers may not be available around the clock in most centers, limiting the use of CCTA. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Computed Tomographic Angiography (CCTA)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 27 Jan 2016to 25 Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients referred from the ED or outpatient service for elective CCTA to rule out CAD
Who may be able to join
- All patients referred for elective CCTA to assess coronary artery disease
Who cannot join
- Patients with previous coronary revascularization procedures (PCI or CABG).
About this study
Official title: Can CCTA Technicians Provide Accurate Interpretation of Findings in Chest Pain Patients Presenting to the Emergency Department in After Hours?
Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice in chest pain patients with low to intermediate probability of coronary artery disease (CAD). Qualified CCTA readers may not be available around the clock in most centers, limiting the use of CCTA. This study aimed to determine if well-qualified CCTA technicians can provide initial accurate diagnosis to guide initial management and triage of such patients
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Computed Tomographic Angiography (CCTA)
- Keywords
- CCTA interpretation, technicians, experts, comparison
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomographic Angiography (CCTA)Diagnostic test
CCTA of coronary arteries
What is being measured
The primary outcome is the main question the study is designed to answer.
The agreements between the two technicians and the cardiologist in evaluation of coronary segments
All coronary segments are independently assesses for CAD by the two technicians and the expert cardiologist
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start27 Jan 2016
- Primary completion25 Feb 2016
- Study completion25 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168269
- Sponsor's protocol ID
- JorCCTA
- Status last verified
- May 2017
- First submitted
- 29 Apr 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can CCTA Technicians Provide Accurate Interpretation of Findings in Chest Pain Patients Presenting to the Emergency Department in After Hours?
- ClinicalTrials.gov ID
- NCT03168269
- Acronym / sponsor ID
- JorCCTA
- Conditions
- Coronary Artery Disease
- Keywords
- CCTA interpretation, technicians, experts, comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 25 Feb 2016 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary Computed Tomographic Angiography (CCTA) is emerging as the diagnostic test of choice in chest pain patients with low to intermediate probability of coronary artery disease (CAD). Qualified CCTA readers may not be available around the clock in most centers, limiting the use of CCTA. This study aimed to determine if well-qualified CCTA technicians can provide initial accurate diagnosis to guide initial management and triage of such patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred from the ED or outpatient service for elective CCTA to rule out CAD
Key inclusion criteria (1 listed)
- All patients referred for elective CCTA to assess coronary artery disease
Key exclusion criteria (1 listed)
- Patients with previous coronary revascularization procedures (PCI or CABG).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Computed Tomographic Angiography (CCTA)CCTA of coronary arteries | Diagnostic test | – |
Primary outcome
The agreements between the two technicians and the cardiologist in evaluation of coronary segments
Time frame: 24 hours
All coronary segments are independently assesses for CAD by the two technicians and the expert cardiologist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Jordan Collaborating Cardiology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The agreements between the two technicians and the cardiologist in evaluation of coronary segments (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.