Clinical trial NCT04986410: Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis
Official title: Quantitative Analysis of Functional Computed Tomography (CT) Imaging of Coronary Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: CT myocardial perfusion imaging
SPECT myocardial perfusion imaging
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with known or suspected CAD

Brief summary: The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD.

Detailed description: Coronary CT angiography (CCTA) has become a reliable diagnostic technique to evaluate coronary artery disease (CAD) with high sensitivity and a negative predictive value. However, CCTA provides only anatomic information and tends to overestimate stenosis severity and is limited in its ability to diagnose myocardial ischemia. Undertaking additional CT myocardial perfusion imaging(CT-MPI) and CT-FFR improves specificity and positive predictive value, reducing unnecessary invasive coronary angiography. The purpose of this prospective observational study is to evaluate the diagnostic and prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function assessment for CAD. SPECT myocardial perfusion imaging (SPECT-MPI)and invasively measured fractional flow reserve (FFR) will serve as the reference standard.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Understand the purpose of the trial, voluntarily participate in this study, and have signed an informed consent form.
3. Patients with known or suspected CAD

Exclusion Criteria:

1. Patients with acute coronary syndrome.
2. Severe cardiac dysfunction (LVEF ≤ 0.3).
3. Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis.
4. Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis.
5. Severe hepatic and renal dysfunction (ALT ≥ 3 Upper Limit of Normal, Cr\> 134μ/mol/L (2mg/dl) or estimated Glomerular Filtration Rate\<45ml/min/1.73m2).
6. Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.)
7. Malignancy or other pathophysiological conditions with an expected survival of less than 1 year
8. Allergic to the drug components involved in this study and those who are intolerant to loading tests
9. Pregnant or lactating women.
10. Mental disorders.
11. Failure to sign the informed consent form.
12. Other conditions that are incompatible with the clinical study.

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 5 years
Secondary outcomes:
measure: Diagnostic performance of CT-MPI
timeFrame: From admission to discharge, up to 1 week
measure: Diagnostic performance of CT-FFR
timeFrame: From admission to discharge, up to 1 week
measure: Diagnostic performance of CT-MPI
timeFrame: From admission to discharge, up to 1 week
measure: Diagnostic performance of CT-FFR
timeFrame: From admission to discharge, up to 1 week
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Mei Zhang
role: STUDY_CHAIR
affiliation: Qilu Hospital of Shandong University
name: Mei Zhang
role: STUDY_DIRECTOR
References: