Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI

• Registration Number: NCT04986410
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-22
• Last Update Submitted: 2021-07-22
• Study First Posted: 2021-08-02
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myocardial Perfusion examination	CCTA, CT-MPI, CT-FFR, SPECT-MPI	-

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	5 years	including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of CT-FFR	From admission to discharge, up to 1 week	Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-FFR to determine the presence/absence of significant coronary artery disease in per-vessel level when compared with invasive FFR and SPECT-MPI.
Diagnostic performance of CT-MPI	From admission to discharge, up to 1 week	Diagnostic accuracy, Sensitivity, specificity, negative predictive value(NPV) and positive predictive value(PPV) of CT-perfusion imaging (quantitative and qualitative analysis) to determine the presence/absence of significant coronary artery disease in per-vessel level when compared with invasive FFR and SPECT-MPI.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China