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Completed

NCT Number: NCT04986410

Quantitative Analysis of Functional 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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with acute coronary syndrome.
  • Severe cardiac dysfunction (LVEF ≤ 0.3).
  • Cardiomyopathy with non-coronary causes such as hypertrophic cardiomyopathy, dilated cardiomyopathy, alcoholic cardiomyopathy, and myocardial amyloidosis.
  • Severe cardiac valve disease with more than moderate valvular regurgitation and/or valvular stenosis.
  • 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).
  • Severe arrhythmias (persistent atrial fibrillation, second-degree or third-degree atrioventricular block, etc.)
  • Malignancy or other pathophysiological conditions with an expected survival of less than 1 year
  • Allergic to the drug components involved in this study and those who are intolerant to loading tests
  • Pregnant or lactating women.
  • Mental disorders.
  • Failure to sign the informed consent form.
  • Other conditions that are incompatible with the clinical study.

Treatment and study plan

CCTA, CT-MPI, CT-FFR, SPECT-MPI

Diagnostic Test

Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI

Primary outcomes

  1. Major Adverse Cardiovascular Events

    Time frame: 5 years

    including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.

Secondary outcomes

  1. Diagnostic performance of CT-MPI

    Time frame: 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 at the subject level when compared with invasive FFR and SPECT-MPI.

  2. Diagnostic performance of CT-FFR

    Time frame: 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 at the subject level when compared with invasive FFR and SPECT-MPI.

  3. Diagnostic performance of CT-MPI

    Time frame: 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.

  4. Diagnostic performance of CT-FFR

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2021
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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