Coronary Artery Disease Clinical Trial
— FOCUS-CCTAOfficial title:
Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
NCT number | NCT02972242 |
Other study ID # | 396906 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | March 2018 |
Verified date | June 2020 |
Source | Walter Reed National Military Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 175 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: 1. Consenting adult patients = 50 years of age; 2. 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 3. Scheduled for non-emergent clinically indicated coronary CT angiography Exclusion Criteria: 1. Prior coronary bypass graft (CABG) surgery 2. Suspicion of acute coronary syndrome (MI or unstable angina) 3. Known complex congenital heart disease 4. 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 5. Atrial fibrillation 6. Abnormal renal function (GFR < 60 ml/min; Creatinine > 1.5 mg/dL) 7. Concomitant participation in another clinical trial in which patient is subject to investigation drug or device 8. Pregnancy or unknown pregnancy status 9. Allergy to iodinated contrast agent 10. Contraindications to nitroglycerin 11. Unwilling or unable to give consent 12. Inability to comply with study procedures 13. Prior coronary artery calcium score and/or coronary CT angiogram |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Walter Reed National Military Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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). | |
Primary | 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. |
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 | 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. | 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 | 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) | 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 | 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. | 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 | 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). | 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 | 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. | 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 | 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. | 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 | 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. | 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). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions
|
N/A |