Radiation SafetyFOCUS-CCTANCT02972242
Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
A study testing Field of View in people with Radiation Safety and Coronary Computed Tomography Angiography, run by Walter Reed National Military Medical Center.
Trial summary
Coronary computed tomography angiography (CCTA) is a frequently performed test for the diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Radiation Safety, Coronary Computed Tomography Angiography, Coronary Artery Disease
- What is being tested?
- Field of View
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adult patients ≥ 50 years of age;
- Suspected but without known prior history of CAD. Prior CAD is defined as a history of myocardial infarction, coronary revascularization or ≥ 50% coronary lumen stenosis on prior coronary angiography
- Scheduled for non-emergent clinically indicated coronary CT angiography
Who cannot join
- Prior coronary bypass graft (CABG) surgery
- Suspicion of acute coronary syndrome (MI or unstable angina)
- Known complex congenital heart disease
- Evidence of ongoing or active clinical instability, including chest pain (sudden onset); cardiogenic shock; unstable blood pressure with systolic blood pressure < 90 mmHg; and severe congestive heart failure (NYHA class III or IV); or acute pulmonary embolism
- Atrial fibrillation
- Abnormal renal function (GFR < 60 ml/min; Creatinine > 1.5 mg/dL)
Show all 13Show fewer
- Concomitant participation in another clinical trial in which patient is subject to investigation drug or device
- Pregnancy or unknown pregnancy status
- Allergy to iodinated contrast agent
- Contraindications to nitroglycerin
- Unwilling or unable to give consent
- Inability to comply with study procedures
- Prior coronary artery calcium score and/or coronary CT angiogram
About this study
Coronary computed tomography angiography (CCTA) is a frequently performed test for the diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected patients. The performance of non-contrast computed tomography for the detection and quantification of coronary calcification is typically performed prior to CCTA in an effort to identify significant calcification which may influence subsequent data acquisition during the CCTA. However, performance of calcium scoring adds significant radiation and most coronary calcification is proximal in its location, potentially visualized using a focused non-contrast scan.
The purpose of this study is to prospectively compare the usefulness of a modified non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as compared to standard coronary artery calcium scanning for the detection of coronary calcification that may influence subsequent CCTA performance.
Read the detailed description
Prior to undergoing CCTA, non-contrast CT scanning of the entire heart is usually performed in adults over 50-years of age in order to assess for the presence and severity of coronary artery calcium. By providing a modified CT scan with a reduced length the same data can be obtained by the imager to ensure a high quality scan while decreasing the patient's overall radiation exposure. Our objectives and specific aims to validate our hypothesis include:
- To assess the impact on CCTA image quality using modified calcium score approach
- To determine the rate of changes in the coronary CT angiography acquisition parameters after evaluation of the modified versus standard calcium scoring scout series. Significant changes in CCTA acquisition include any of the following as compared to recommended CCTA parameters prior to scout CT performance: a change (increase or decrease) in tube current (mA) by 50, any change in tube potential (kV), change to/from retrospectively-gated CCTA, any change in padding (acquisition window), or changing to/from a high definition CT scan acquisition.
- To assess the difference in patient estimated effective radiation exposure (mSv) between the modified versus standard calcium scoring techniques.
- To assess the difference in patient estimated effective radiation exposure (mSv) of the entire CCTA study (plus calcium scoring) between groups.
Study Design Prospective, randomized single-center cohort study.
Anticipated Requirements
- Facilities: Walter Reed National Military Medical Center
- Cardiology Clinic
- Cardiovascular Health and Interventional Radiology, Angiography and Recovery [CVHIR]
- Radiology Department (CT Section)
- Duration of enrollment: 12 months
- Budget: no additional budget is needed.
Subject Population
- One hundred seventy-five (175) male and female adult subjects (military health beneficiaries age greater than 50 years) who are clinically referred for CCTA will be eligible for participation.
- The Walter Reed National Military Medical Center Cardiology Department and Radiology Departments perform multiple clinically appropriate and indicated coronary CTA studies weekly (approximately 8-12), which will allow for ease of subject recruitment. Although there are other open studies using CCTA in our department there is not a lot of overlap in their requirements and should not prohibit enrollment in our study. This study will enroll both men and women of all ethnic origins aged ≥ 50 years. All subjects will consent for themselves. All patients' participation in this research and subsequent contribution to our medical knowledge notwithstanding, no intent to benefit patients from enrollment is implied or offered. Pregnant women will be excluded from enrollment based on:
- Verbal admission of pregnant status; OR
- Positive urine pregnancy test performed within 7 days of CCTA in subjects not previously known to be pregnant.
- Being tested
- Field of View
- 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.
Field of ViewRadiation
Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Modified Field of View | Active comparator | In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium. Receives: Radiation: Field of View |
| Standard Field of View | Placebo comparator | In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms. Receives: Radiation: Field of View |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Quality Comparison
The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale).
- = Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast.
- = Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis.
- = Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque.
- = Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Quantitative Quality Comparison
The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio):
image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA "signal" and standard deviation of the HU within that same region (which is the "noise"), the ratio of these signal/noise is also captured by this method.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Secondary outcomes (7)
Number of Patients With Coronary CT Parameter Changes (mA by 50).
Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in a change in milliamps by 50.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Patients With Coronary CT Parameter Changes (Tube Potential).
Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring (i.e. increasing or decreasing the tube potential)
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Patients With Coronary CT Using High Definition Scanning.
Any use of of the "high definition" scanning parameter after evaluation of the calcium burden by modified or standard calcium scoring.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).
Any changes in the cardiac CT after evaluation of the modified or standard calcium scoring in any changes in padding (milliseconds).
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Comparison Radiation Exposure in Non-Con CT (Dose Length Product)
The measurement of radiation exposure as DLP (measured in mSv/mGycm) in comparison of the modified versus standard calcium scoring.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)
The measurement of radiation exposure difference measured as DLP/milli-sieverts of the entire CCTA study on the modified versus standard calcium scoring.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Participants for Which There Was a Scan Termination Event
Number of patients whose coronary CTA scan was canceled by the imaging provider due to extreme levels of calcium noted during the modified or standard calcium scoring scan.
Measured: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation SafetyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Hampton Crimm, Walter Reed National Military Medical Center
- Investigators
- Hampton A Crimm, MD, Principal investigator, WRNMMC Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972242
- Sponsor's protocol ID
- 396906
- Acronym
- FOCUS-CCTA
- Status last verified
- Jun 2020
- First submitted
- 18 Nov 2016
- Last updated
- 22 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Crimm HA, Fergestrom NM, Dye C, Philip C, Nguyen BT, Villines TC. Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial. J Cardiovasc Comput Tomogr. 2021 May-Jun;15(3):240-245. doi: 10.1016/j.jcct.2020.08.011. Epub 2020 Aug 22.
PubMed 32868247
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
- ClinicalTrials.gov ID
- NCT02972242
- Acronym / sponsor ID
- FOCUS-CCTA / 396906
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Nov 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 22 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary computed tomography angiography (CCTA) is a frequently performed test for the diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected patients. The performance of non-contrast computed tomography for the detection and quantification of coronary calcification is typically performed prior to CCTA in an effort to identify significant calcification which may influence subsequent data acquisition during the CCTA. However, performance of calcium scoring adds significant radiation and most coronary calcification is proximal in its location, potentially visualized using a focused non-contrast scan.
The purpose of this study is to prospectively compare the usefulness of a modified non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as compared to standard coronary artery calcium scanning for the detection of coronary calcification that may influence subsequent CCTA performance.
Detailed description
Prior to undergoing CCTA, non-contrast CT scanning of the entire heart is usually performed in adults over 50-years of age in order to assess for the presence and severity of coronary artery calcium. By providing a modified CT scan with a reduced length the same data can be obtained by the imager to ensure a high quality scan while decreasing the patient's overall radiation exposure. Our objectives and specific aims to validate our hypothesis include:
- To assess the impact on CCTA image quality using modified calcium score approach
- To determine the rate of changes in the coronary CT angiography acquisition parameters after evaluation of the modified versus standard calcium scoring scout series. Significant changes in CCTA acquisition include any of the following as compared to recommended CCTA parameters prior to scout CT performance: a change (increase or decrease) in tube current (mA) by 50, any change in tube potential (kV), change to/from retrospectively-gated CCTA, any change in padding (acquisition window), or changing to/from a high definition CT scan acquisition.
- To assess the difference in patient estimated effective radiation exposure (mSv) between the modified versus standard calcium scoring techniques.
- To assess the difference in patient estimated effective radiation exposure (mSv) of the entire CCTA study (plus calcium scoring) between groups.
Study Design Prospective, randomized single-center cohort study.
Anticipated Requirements
- Facilities: Walter Reed National Military Medical Center
- Cardiology Clinic
- Cardiovascular Health and Interventional Radiology, Angiography and Recovery [CVHIR]
- Radiology Department (CT Section)
- Duration of enrollment: 12 months
- Budget: no additional budget is needed.
Subject Population
- One hundred seventy-five (175) male and female adult subjects (military health beneficiaries age greater than 50 years) who are clinically referred for CCTA will be eligible for participation.
- The Walter Reed National Military Medical Center Cardiology Department and Radiology Departments perform multiple clinically appropriate and indicated coronary CTA studies weekly (approximately 8-12), which will allow for ease of subject recruitment. Although there are other open studies using CCTA in our department there is not a lot of overlap in their requirements and should not prohibit enrollment in our study. This study will enroll both men and women of all ethnic origins aged ≥ 50 years. All subjects will consent for themselves. All patients' participation in this research and subsequent contribution to our medical knowledge notwithstanding, no intent to benefit patients from enrollment is implied or offered. Pregnant women will be excluded from enrollment based on:
- Verbal admission of pregnant status; OR
- Positive urine pregnancy test performed within 7 days of CCTA in subjects not previously known to be pregnant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Field of View | Active comparator | Radiation: Field of ViewIn patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium. |
| Standard Field of View | Placebo comparator | Radiation: Field of ViewIn patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consenting adult patients ≥ 50 years of age;
- Suspected but without known prior history of CAD. Prior CAD is defined as a history of myocardial infarction, coronary revascularization or ≥ 50% coronary lumen stenosis on prior coronary angiography
- Scheduled for non-emergent clinically indicated coronary CT angiography
Key exclusion criteria (13 listed)
- Prior coronary bypass graft (CABG) surgery
- Suspicion of acute coronary syndrome (MI or unstable angina)
- Known complex congenital heart disease
- Evidence of ongoing or active clinical instability, including chest pain (sudden onset); cardiogenic shock; unstable blood pressure with systolic blood pressure < 90 mmHg; and severe congestive heart failure (NYHA class III or IV); or acute pulmonary embolism
- Atrial fibrillation
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 |
|---|---|---|
| Field of ViewNon-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography | Radiation | Modified Field of View, Standard Field of View |
Primary outcome
Qualitative Quality Comparison
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale). 1. = Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast. 2. = Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis. 3. = Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque. 4. = Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.
Quantitative Quality Comparison
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio): image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA "signal" and standard deviation of the HU within that same region (which is the "noise"), the ratio of these signal/noise is also captured by this method.
7 secondary outcomes
Number of Patients With Coronary CT Parameter Changes (mA by 50).
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Patients With Coronary CT Parameter Changes (Tube Potential).
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Patients With Coronary CT Using High Definition Scanning.
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Comparison Radiation Exposure in Non-Con CT (Dose Length Product)
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts)
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Number of Participants for Which There Was a Scan Termination Event
Time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32868247Crimm HA, Fergestrom NM, Dye C, Philip C, Nguyen BT, Villines TC. Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial. J Cardiovasc Comput Tomogr. 2021 May-Jun;15(3):240-245. doi: 10.1016/j.jcct.2020.08.011. Epub 2020 Aug 22.
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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.
Hampton A Crimm, MD principal investigator
WRNMMC Cardiology Department
Questions about this trial
What is this clinical trial studying?
A study testing Field of View in people with Radiation Safety and Coronary Computed Tomography Angiography, run by Walter Reed National Military Medical Center.
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 3 inclusion and 13 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 22 Jun 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Qualitative Quality Comparison (time frame: Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972242, which also lists 1 linked publication.
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 22 Jun 2020.