Treatment Decision, Coronary Artery DiseaseNCT06119022
CT Myocardial Perfusion to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease (POTENTIAL)
A study testing Invasive coronary angiography and routine medical treatment in people with Treatment Decision, Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites in China.
Trial summary
The overall goal of this project is to compare the non-revascularization rate of coronary angiography in patients with stable coronary artery disease (CAD) within 90 days after CT myocardial perfusion imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI), and 1-year… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Treatment Decision, Coronary Artery Disease
- What is being tested?
- Invasive coronary angiography and routine medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 4 sitesChina
- Study dates
- 30 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients with stable chest pain who have undergone coronary CT angiography and have 50-90% stenosis in at least one vessel > 2mm in diameter
- Able to provide signed informed consent
Who cannot join
- Suspected or confirmed acute coronary syndrome
- Evidence of clinical instability or need for an emergent procedure
- History of percutaneous coronary stent implantation, history of coronary artery bypass grafting, or history of myocardial infarction
- Left main artery stenosis ≥ 50%
- Severe heart failure (New York Heart Association (NYHA) ≥III)
- Estimated glomerular filtration rate < 60 mL/min/1.73 m2
Show all 15Show fewer
- Contraindicated to use contrast agents, beta-blockers, nitrates or adenosine drugs
- Acute episodes of bronchial asthma or chronic obstructive pulmonary disease
- II or III degree atrioventricular block
- History of pacemaker or implantable cardioverter defibrillator implantation
- Combined with other cardiovascular diseases including cardiomyopathy, congenital heart disease, valvular heart disease, pulmonary vascular disease, pericardial disease, etc
- Pregnant or trying to be pregnant
- Combined with any other serious disease, life expectancy <1 year
- Any condition leading to possible inability to comply with the protocol procedures and follow-up
- Currently participating in any other clinical trials
Trial locations and contacts
4 sites in 1 country.
China4 sites, 1 recruiting
- Recruiting
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yang Gao, M.D, 86-10-88322656, gaoyang226@126.com
Qingchao Meng, M.D, 86-10-88322658, mengqc141728@163.com
- Active, not recruiting
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin
- Active, not recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
- Active, not recruiting
The First Affiliated Hosptial of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
The overall goal of this project is to compare the non-revascularization rate of coronary angiography in patients with stable coronary artery disease (CAD) within 90 days after CT myocardial perfusion imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI), and 1-year major adverse cardiovascular events (MACE).
Read the detailed description
Participants will be patients with proven coronary artery disease (CAD) who are scheduled randomized to undergo CT Myocardial Perfusion Imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI) to evaluate myocardium ischemia. Those patients with positive myocardial ischemia will scheduled to undergo invasive coronary angiography (ICA), and those without myocardial ischemia will have optical medical therapy. The purpose of the study is to verify that CT-MPI guided clinical pathways are not inferior to SPECT-MPI pathways in downstream treatment decision making and safety assessment. In order to achieve this aim, the study team will compare the non-revascularization rate of ICA within 90 days after CT-MPI and SPECT-MPI. 1-year major adverse cardiovascular events (MACE) will be also compared.
- Being tested
- Invasive coronary angiography, routine medical treatment
- Keywords
- CT myocardial perfusion imaging, Coronary artery disease, clinical pathway, 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.
Invasive coronary angiographyProcedure or surgery
Patients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography.
routine medical treatmentOther
Patients with negative myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to have routine medical therapy instead of invasive coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| CT-MPI guided without myocardial ischemia | Experimental | There was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI Receives: Other: routine medical treatment |
| CT-MPI guided with myocardial ischemia | Experimental | There was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI Receives: Procedure: Invasive coronary angiography |
| SPECT-MPI guided without myocardial ischemia | Active comparator | There was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI Receives: Other: routine medical treatment |
| SPECT-MPI guided with myocardial ischemia | Active comparator | There was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI Receives: Procedure: Invasive coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of non-revascularization treatment of the two arms
The incidence of conventional angiography not leading to revascularization within 90 days after CT-MPI or SPECT-MPI.
Measured: within 90 days after CT-MPI or SPECT-MPI examination
Secondary outcomes (4)
The rate of major adverse cardiovascular events of the two arms
The composition of all-cause death, non-fatal myocardial infarction, stroke, revascularization, and hospital admissions for unstable angina.
Measured: One year after CT-MPI or SPECT-MPI
Difference in quality of Life of the two arms
The Seattle Angina Questionnaire
Measured: One year after CT-MPI or SPECT-MPI
Difference in cost of the two arms
Total clinical cost
Measured: One year after CT-MPI or SPECT-MPI
Difference in cumulative radiation exposure dose of the two arms
Total cumulative radiation exposure dose
Measured: Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start30 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Decision, Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119022
- Sponsor's protocol ID
- 2023-GSP-GG-21
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Myocardial Perfusion Imaging to Guide the Diagnosis and Treatment of Patients With Stable Coronary Artery Disease: a Randomized Controlled Study (POTENTIAL)
- ClinicalTrials.gov ID
- NCT06119022
- Acronym / sponsor ID
- 2023-GSP-GG-21
- Keywords
- CT myocardial perfusion imaging, Coronary artery disease, clinical pathway, SPECT myocardial perfusion imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (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 overall goal of this project is to compare the non-revascularization rate of coronary angiography in patients with stable coronary artery disease (CAD) within 90 days after CT myocardial perfusion imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI), and 1-year major adverse cardiovascular events (MACE).
Detailed description
Participants will be patients with proven coronary artery disease (CAD) who are scheduled randomized to undergo CT Myocardial Perfusion Imaging (CT-MPI) or Single-Photon Emission Computed Tomography myocardial perfusion imaging (SPECT-MPI) to evaluate myocardium ischemia. Those patients with positive myocardial ischemia will scheduled to undergo invasive coronary angiography (ICA), and those without myocardial ischemia will have optical medical therapy. The purpose of the study is to verify that CT-MPI guided clinical pathways are not inferior to SPECT-MPI pathways in downstream treatment decision making and safety assessment. In order to achieve this aim, the study team will compare the non-revascularization rate of ICA within 90 days after CT-MPI and SPECT-MPI. 1-year major adverse cardiovascular events (MACE) will be also compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT-MPI guided without myocardial ischemia | Experimental | Other: routine medical treatmentThere was no evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI |
| CT-MPI guided with myocardial ischemia | Experimental | Procedure: Invasive coronary angiographyThere was positive evidence of myocardial ischemia in patients with coronary heart disease by CT-MPI |
| SPECT-MPI guided without myocardial ischemia | Active comparator | Other: routine medical treatmentThere was no evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI |
| SPECT-MPI guided with myocardial ischemia | Active comparator | Procedure: Invasive coronary angiographyThere was positive evidence of myocardial ischemia in patients with coronary heart disease by SPECT-MPI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Patients with stable chest pain who have undergone coronary CT angiography and have 50-90% stenosis in at least one vessel > 2mm in diameter
- Able to provide signed informed consent
Key exclusion criteria (15 listed)
- Suspected or confirmed acute coronary syndrome
- Evidence of clinical instability or need for an emergent procedure
- History of percutaneous coronary stent implantation, history of coronary artery bypass grafting, or history of myocardial infarction
- Left main artery stenosis ≥ 50%
- Severe heart failure (New York Heart Association (NYHA) ≥III)
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 |
|---|---|---|
| Invasive coronary angiographyPatients with positive myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to undergo invasive coronary angiography. | Procedure or surgery | CT-MPI guided with myocardial ischemia, SPECT-MPI guided with myocardial ischemia |
| routine medical treatmentPatients with negative myocardial ischemia either in CT-MPI guided arm or SPECT-MPI guided arm will scheduled to have routine medical therapy instead of invasive coronary angiography. | Other | CT-MPI guided without myocardial ischemia, SPECT-MPI guided without myocardial ischemia |
Primary outcome
The rate of non-revascularization treatment of the two arms
Time frame: within 90 days after CT-MPI or SPECT-MPI examination
The incidence of conventional angiography not leading to revascularization within 90 days after CT-MPI or SPECT-MPI.
4 secondary outcomes
The rate of major adverse cardiovascular events of the two arms
Time frame: One year after CT-MPI or SPECT-MPI
Difference in quality of Life of the two arms
Time frame: One year after CT-MPI or SPECT-MPI
Difference in cost of the two arms
Time frame: One year after CT-MPI or SPECT-MPI
Difference in cumulative radiation exposure dose of the two arms
Time frame: Total cumulative radiation exposure dose during CT-MPI or SPECT-MPI and invasive coronary angiography within one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Treatment Decision, Coronary Artery Disease
Not yet recruiting
Heart tEam Decision-making Assisted by Revaz AI Trial
Coronary Artery Disease
Recruiting
Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease
Coronary Artery Disease Left Main, Coronary Artery Disease
Active, not recruiting
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Type 2 Diabetes Mellitus, Obesity
Not yet recruiting
Coronary Computed Tomographic Angiography Combined With CT-FFR in Intermediate-Risk Chest Pain Patients.
Chest Pain, Coronary Artery Disease
Not yet recruiting
DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid
Acute Coronary Syndrome
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive coronary angiography and routine medical treatment in people with Treatment Decision, Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 4 sites 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 15 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Gao, M.D (86-10-88322656, gaoyang226@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of non-revascularization treatment of the two arms (time frame: within 90 days after CT-MPI or SPECT-MPI examination). 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 7 Nov 2023.