Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

Coronary Artery Disease Clinical Trial

Official title:

Quantitative Analysis of Functional Computed Tomography (CT) Imaging of Coronary Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986410
• Other study ID #: 2016YFC1300302
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• CCTA, CT-MPI, CT-FFR, SPECT-MPI
Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.	5 years
Secondary	Diagnostic performance of CT-MPI	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 at the subject level when compared with invasive FFR and SPECT-MPI.	From admission to discharge, up to 1 week
Secondary	Diagnostic performance of CT-FFR	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 at the subject level when compared with invasive FFR and SPECT-MPI.	From admission to discharge, up to 1 week
Secondary	Diagnostic performance of CT-MPI	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.	From admission to discharge, up to 1 week
Secondary	Diagnostic performance of CT-FFR	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.	From admission to discharge, up to 1 week