Coronary Artery DiseaseNCT04986410
Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis
An observational study of Coronary Artery Disease, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CCTA, CT-MPI, CT-FFR, SPECT-MPI
- How many people
- 640 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with known or suspected CAD
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- CCTA, CT-MPI, CT-FFR, SPECT-MPI
- Keywords
- CT myocardial perfusion imaging, SPECT myocardial perfusion imaging
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA, CT-MPI, CT-FFR, SPECT-MPIDiagnostic test
Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Perfusion examination | Not described Receives: Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
including cardiac death, all-cause death, acute coronary syndrome, readmission for acute coronary syndrome or heart failure, and Revascularization.
Measured: 5 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to discharge, up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Jul 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei Zhang, Study chair, Qilu Hospital of Shandong UniversityMei Zhang, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986410
- Sponsor's protocol ID
- 2016YFC1300302
- Status last verified
- Jun 2021
- First submitted
- 11 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of Functional Computed Tomography (CT) Imaging of Coronary Atherosclerosis
- ClinicalTrials.gov ID
- NCT04986410
- Acronym / sponsor ID
- 2016YFC1300302
- Conditions
- Coronary Artery Disease
- Keywords
- CT myocardial perfusion imaging, SPECT myocardial perfusion imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial Perfusion examination | – | Diagnostic Test: CCTA, CT-MPI, CT-FFR, SPECT-MPI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected CAD
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA, CT-MPI, CT-FFR, SPECT-MPISubjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI | Diagnostic test | Myocardial Perfusion examination |
Primary outcome
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.
4 secondary outcomes
Diagnostic performance of CT-MPI
Time frame: From admission to discharge, up to 1 week
Diagnostic performance of CT-FFR
Time frame: From admission to discharge, up to 1 week
Diagnostic performance of CT-MPI
Time frame: From admission to discharge, up to 1 week
Diagnostic performance of CT-FFR
Time frame: From admission to discharge, up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei Zhang study chair
Qilu Hospital of Shandong University
Mei Zhang study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.