Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: CCTA, CT-MPI, CT-FFR, SPECT-MPI

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 Type: Observational
• Enrollment (Actual): 640

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected CAD

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myocardial Perfusion examination	Diagnostic test: CCTA, CT-MPI, CT-FFR, SPECT-MPI; Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Chair: Mei Zhang, Qilu Hospital of Shandong University; Study Director: Mei Zhang, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: CT myocardial perfusion imaging; SPECT myocardial perfusion imaging
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: 2016YFC1300302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No