search
Back to results

Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup (FAST-CCT)

Primary Purpose

Coronary Stenosis, Aortic Valve Stenosis, Cardiovascular Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aortic CTA, .23s
Aortic CTA, .28s
Sponsored by
David C. Rotzinger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Stenosis focused on measuring Computed Tomography Angiography, Artifacts, Diagnostic imaging, Image Processing, Computer-Assisted

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjected to cardiac CT due to known or suspected aortic valve stenosis Exclusion Criteria: Patients unable to hold their breath, deaf or visually impaired Estimated glomerular filtration rate (eGFR) of <30 mL/min Hemodynamic instability or cardiogenic shock, Acute pulmonary edema, Exacerbated chronic obstructive pulmonary disease, Pregnant and breast-feeding women Patients with prior coronary artery bypass grafting (CABG) Patient incapable of discernment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    Patients subjected to aortic CTA with a gantry revolution time of 0.23 sec

    Patients subjected to aortic CTA with a gantry revolution time of 0.28 sec

    Outcomes

    Primary Outcome Measures

    Interpretable CTA rate per patient
    Number of patients with diagnostic image quality for coronary artery disease

    Secondary Outcome Measures

    Interpretable CTA rate, per segment
    Number of segments with diagnostic image quality for coronary artery disease
    CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard
    CTA's diagnostic accuracy for coronary occlusive disease
    Relationship between heart rate and non-diagnostic CTA
    Correlation between of heart rate (in BPM) and the presence of any uninterpretable coronary segment on CTA
    Quantitative image quality (contrast to noise ratio)
    Comparison of contrast to noise ratio between both groups
    Radiation dose per patient
    Effective dose (mSv) comparison between both groups

    Full Information

    First Posted
    January 11, 2023
    Last Updated
    January 23, 2023
    Sponsor
    David C. Rotzinger
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05709652
    Brief Title
    Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup
    Acronym
    FAST-CCT
    Official Title
    Impact of Fast Gantry Rotation Cardiac CT Angiography on Coronary Motion Artifacts in the Absence of β-Blocker Premedication in Patients Undergoing Aortic Stenosis Workup: a Single-centre Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    March 3, 2025 (Anticipated)
    Study Completion Date
    March 3, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    David C. Rotzinger

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the workup of aortic stenosis. Patients will be randomly assigned .23 or .28 sec rotation time CTA. Coronary artery interpretability rates will be determined in both groups.
    Detailed Description
    Coronary artery analysis is an essential component of cardiac CT, but is often challenging without beta-blocker use. CT's technological advances are continuously evolving, paving the way for safer and more accurate diagnoses. Part of these innovations is the development of faster rotation speeds (0.23 sec/rotation), which is expected to allow for heart rate-independent CCTA. Patients subjected to aortic stenosis workup routinely undergo invasive coronary angiography (ICA) in the catheterization laboratory, voiding the need to control the heart rate at the time of cardiac CT because aortic valve measurements can be performed even at higher heart rate. Still, cardiac CT in this context is performed with ECG-gating, and attempting to evaluate coronary arteries is possible without interfering with clinical decisions. Also, the existing literature advocates the use of gantry rotation speeds of at least 0.5 sec/rotation; consequently, the use of 0.28 versus 0.23 sec/rotation for this study will comply with current guidelines and will have no detrimental impact on patient management. This study aims to evaluate coronary artery interpretability in patients subjected to cardiac CT for the anatomical assessment of aortic valve stenosis prior to endovascular (transcatheter aortic valve implantation [TAVI]) or surgical therapy. Patients will be enrolled after providing written, informed consent, and will be randomly assigned either to the test (0.23 sec rotation time) or control group (0.28 sec rotation). The participants concerned are not subjected to any additional invasive or stressful procedure compared with those undergoing aortic stenosis workup in clinical routine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Stenosis, Aortic Valve Stenosis, Cardiovascular Diseases
    Keywords
    Computed Tomography Angiography, Artifacts, Diagnostic imaging, Image Processing, Computer-Assisted

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    124 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    Patients subjected to aortic CTA with a gantry revolution time of 0.23 sec
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients subjected to aortic CTA with a gantry revolution time of 0.28 sec
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Aortic CTA, .23s
    Other Intervention Name(s)
    GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 230 ms rotation time
    Intervention Description
    Aortic CTA performed with short (0.23 sec) gantry rotation time.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Aortic CTA, .28s
    Other Intervention Name(s)
    GE Healthcare, Revolution Apex, cardiac and aortic CT angiography with 280 ms rotation time
    Intervention Description
    Aortic CTA performed with standard (.28 sec) gantry rotation time.
    Primary Outcome Measure Information:
    Title
    Interpretable CTA rate per patient
    Description
    Number of patients with diagnostic image quality for coronary artery disease
    Time Frame
    Up to 90 days
    Secondary Outcome Measure Information:
    Title
    Interpretable CTA rate, per segment
    Description
    Number of segments with diagnostic image quality for coronary artery disease
    Time Frame
    Up to 90 days
    Title
    CTA performance to measure diameter stenosis, using invasive coronary angiography as gold standard
    Description
    CTA's diagnostic accuracy for coronary occlusive disease
    Time Frame
    Coronary angiography performed withing 30 days of CTA
    Title
    Relationship between heart rate and non-diagnostic CTA
    Description
    Correlation between of heart rate (in BPM) and the presence of any uninterpretable coronary segment on CTA
    Time Frame
    Up to 90 days
    Title
    Quantitative image quality (contrast to noise ratio)
    Description
    Comparison of contrast to noise ratio between both groups
    Time Frame
    Up to 90 days
    Title
    Radiation dose per patient
    Description
    Effective dose (mSv) comparison between both groups
    Time Frame
    Up to 90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjected to cardiac CT due to known or suspected aortic valve stenosis Exclusion Criteria: Patients unable to hold their breath, deaf or visually impaired Estimated glomerular filtration rate (eGFR) of <30 mL/min Hemodynamic instability or cardiogenic shock, Acute pulmonary edema, Exacerbated chronic obstructive pulmonary disease, Pregnant and breast-feeding women Patients with prior coronary artery bypass grafting (CABG) Patient incapable of discernment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David C Rotzinger, MD, PhD
    Phone
    021 314 44 75
    Email
    david.rotzinger@chuv.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David C. Rotzinger, MD, PhD
    Organizational Affiliation
    CHUV
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup

    We'll reach out to this number within 24 hrs