Coronary Artery DiseaseMY-FUSIONNCT06670768
Myocardial Perfusion Quantification With SPECT Using Multi-Pinhole Collimator Compared to Photon-Counting Coronary CTA
A study testing Stress Dynamic MPI SPECT, Stress Static MPI SPECT and Rest Dynamic MPI SPECT in people with Coronary Artery Disease and Coronary Computed Tomography Angiography, run by Semmelweis University at 1 site in Hungary.
Trial summary
This prospective study aims to compare functional abnormalities detected using myocardial perfusion SPECT imaging (MPI SPECT) with the extent and severity of anatomical findings on coronary computed tomography angiography (coronary CTA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Computed Tomography Angiography, SPECT
- What is being tested?
- Stress Dynamic MPI SPECT, Stress Static MPI SPECT and Rest Dynamic MPI SPECT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 6 Mar 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected coronary artery disease
- referred to coronary CTA or SPECT MPI by the patient's physician
- agrees to the other imaging modality that was not indicated by their physician (coronary CTA or SPECT MPI)
- suitable for informed consent
Who cannot join
- moderate or severe aortic valve stenosis
- atrial fibrillation
- pregnancy or breastfeeding
- history of coronary artery bypass graft implantation
- history of stent implantation
- chronic renal failure (eGFR < 30 ml/m2)
Show all 9Show fewer
- active oncological treatment
- congenital heart disease
- left or right bundle branch block
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Medical Imaging Centre
Budapest, Budapest, 1083
Pál Maurovich-Horvat, MD, PhD, MPH, +36206632485, maurovich-horvat.pal@semmelweis.hu
About this study
Official title: Myocardial Perfusion Quantification With Single Photon Emission Computed Tomography Using Multi-Pinhole Collimator Compared to Photon-Counting Coronary Computed Tomography Angiography
This prospective study aims to compare functional abnormalities detected using myocardial perfusion SPECT imaging (MPI SPECT) with the extent and severity of anatomical findings on coronary computed tomography angiography (coronary CTA). Additionally, the investigators aim to enhance the diagnostic value of MPI SPECT by quantifying myocardial blood flow and utilizing myocardial flow reserve calculated from dynamic SPECT images.
50 patients with suspected coronary artery disease are anticipated to be enrolled. Pharmacological stress and rest-phase dynamic and static MPI SPECT following an additional coronary CTA scan are to be performed. The obtained multimodality imaging data (functional and anatomical parameters) are planned to be compared and subjected to statistical analysis. The results of this study are expected to improve risk assessment for patients with moderate cardiovascular risk and enhance the diagnostic performance of MPI SPECT.
Read the detailed description
Diagnostic management of patients with moderate clinical likelihood of obstructive coronary artery disease (CAD) remains challenging. Myocardial perfusion SPECT imaging (MPI SPECT) is a widely available and cost-effective modality that provides functional information on segmental perfusion defects. However, conventional static MPI SPECT has moderate diagnostic performance in identifying subclinical coronary atherosclerosis.
The novel multi-pinhole (MPH) collimator technology with a three-detector SPECT camera (AnyScan® TRIO SPECT/CT, Mediso Ltd., Hungary) enables temporal and spatial resolution, absolute quantification of stress and rest myocardial blood flow (sMBF and rMBF), and calculated myocardial flow reserve (MFR), overcoming the difficulties of semi-quantitative evaluation.
This study aims to investigate the association between quantitative MFR, semi-quantitative functional parameters of dynamic, static MPI SPECT, and coronary CTA-based plaque metrics. Flow parameters of myocardial wall segments will be corresponded to the appropriate coronary artery based on the CT-assessed anatomy. Furthermore, the investigators aim to build statistical models representative of clinical scenarios to test the diagnostic accuracy of the MPH collimator.
In this prospective study, 50 patients with moderate cardiovascular pre-test probability (PTP) referred to either coronary CTA or MPI SPECT are anticipated to be enrolled. Cardiovascular PTP is estimated according to the CAD consortium based on age, sex, type of chest pain, and cardiovascular risk factors. Patients with a history of coronary artery bypass graft implantation, left or right bundle branch block, and atrial fibrillation will be excluded. Participants will be subjected (1) to dynamic and (2) static MPI SPECT (pharmacological stress and rest) and (3) to coronary CTA within 30 days. Patients undergoing pharmacological stress (dipyridamole or adenosine) dynamic MPI SPECT, which will be performed with AnyScan® TRIO SPECT/CT (Mediso Ltd.). Imaging will be started at the time of the radiopharmaceutical administration both in stress and rest, captured for 15 minutes in list mode. BMI-standardized doses of 99m-Tc will be used, with a same-day acquisition protocol, resulting in a three-fold increase for the rest phase compared to stress. Following each phase of dynamic acquisition in 30-60 minutes, an ECG-gated static MPI SPECT will be performed using a conventional LEHR collimator.
Data, such as sMBF, rMBF, MFR, summed stress score (SSS), summed rest score (SRS), summed difference score (SDS), as well as visually evaluated perfusion defect severity and extent will be determined from MPI SPECT. Within 30 days of MPI SPECT, coronary CTA with Calcium Score assessment will also be performed using a photon-counting detector CT (NAEOTON Alpha, Siemens Healthineers, Germany). Coronary CTA will be analyzed as follows: coronary artery calcium score (CACS), the severity of luminal stenosis, total plaque volume, quantitative plaque composition, and CT-derived fractional flow reserve (FFR). The following additional anamnestic covariants will be used: age, sex, and cardiovascular risk factors such as type of chest pain, diabetes mellitus, hypertension, smoking, obesity, and dyslipidemia.
The investigators hypothesized that dynamic MPI SPECT may prove to be superior to semi-quantitative static MPI SPECT in detecting CAD. Furthermore, MFR data combined with CACS may improve the diagnostic accuracy of MPI SPECT and guide the selection of patients for invasive coronary angiography.
MPI SPECT and coronary CTA data will be analyzed on-site at Semmelweis University, Hungary. The results will be available after the completion of patient enrollment.
- Conditions
- Coronary Artery Disease, Coronary Computed Tomography Angiography, SPECT, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Being tested
- Stress Dynamic MPI SPECT, Stress Static MPI SPECT, Rest Dynamic MPI SPECT, Rest Static MPI SPECT, Cardiac CT
- Keywords
- Coronary Artery Disease,, Myocardial Perfusion Imaging, Myocardial Perfusion Imaging Absolute Quantification, Myocardial Flow Reserve, Plaque volume
- Medical subject headings
- Coronary Artery Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Myocardial Ischemia, Coronary Disease, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Dynamic MPI SPECTDiagnostic test
BMI standardized radiopharmaceutical injection in pharmacological stress (dipyridamole or adenosine) is performed under the SPECT camera to record the temporal distribution of the activity. A one-day protocol and multi-pinhole collimator are used.
Stress Static MPI SPECTDiagnostic test
30-60 minutes after stress dynamic SPECT imaging is performed, an ECG-gated static SPECT MPI is conducted with a conventional LEHR collimator.
Rest Dynamic MPI SPECTDiagnostic test
3 hours after the stress phase, the rest phase is also recorded. A radiopharmaceutical injection with a three-fold dose at rest is performed under the SPECT camera to record the temporal distribution of the activity. A one-day protocol and multi-pinhole collimator are used.
Rest Static MPI SPECTDiagnostic test
30-60 minutes after rest, dynamic SPECT imaging is performed, and an ECG-gated static SPECT MPI is conducted with a conventional LEHR collimator.
Cardiac CTDiagnostic test
Within 30 days of MPI SPECT imaging, a cardiac CT is performed for every patient, including a native calcium-scoring scan and a coronary CT angiography as a reference standard. A photon-counting detector CT is used.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive patients with moderate pre-test probability according to CAD consortium | Experimental | Patients undergo dynamic and static MPI SPECT and cardiac CT within 30-days. Receives: Diagnostic Test: Stress Dynamic MPI SPECT; Diagnostic Test: Stress Static MPI SPECT; Diagnostic Test: Rest Dynamic MPI SPECT; Diagnostic Test: Rest Static MPI SPECT; Diagnostic Test: Cardiac CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between Myocardial Flow Reserve (MFR) and total non-calcified plaque volume as assessed by coronary CTA.
Predictive value of MFR on vessel and participant level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF). The total non-calcified plaque volume will be measured by PCD-CT.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Secondary outcomes (12)
Predictive Value of Myocardial Flow Reserve (MFR) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of MFR on vessel and participant levels is expressed as the ratio of stress/rest myocardial blood flow (sMBF/rMBF) to FFR-CT of 0.8 or less in any coronary artery. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of stress Myocardial Blood Flow (sMBF) to lumen stenosis extent on coronary CTA
The predictive value of sMBF on vessel and participant level, derived from dynamic MPI SPECT, expressed in unit of ml/min/g to luminal stenosis extent. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of stress Myocardial Blood Flow (sMBF) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of sMBF on vessel and participant levels, derived from dynamic MPI SPECT, is expressed in a unit of ml/min/g to FFR-CT of 0.8 or less in any coronary artery. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Correlation of Myocardial Flow Reserve (MFR) and quantitative plaque composition
Correlation of MFR on vessel level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF) and plaque composition. Plaque components are defined based on the following Hounsfield Unit (HU) threshold ranges: Low-attenuation plaque: - 100 to 30 HU; Non-calcified plaque: 30 to 350 HU; Calcified plaque: above 350 HU.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Stress Score (SSS) to lumen stenosis extent on coronary CTA.
The predictive value of semi-quantitative SSS derived from static MPI SPECT using a dedicated software on vessel and participant level to lumen stenosis extent. Classification of SSS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Stress Score (SSS) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of semi-quantitative SSS derived from static MPI SPECT using a dedicated software on vessel and participant level to FFR-CT of 0.8 or less in any coronary artery. Classification of SSS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Difference Score (SDS) to lumen stenosis extent on coronary CTA.
The predictive value of semi-quantitative SDS derived from static MPI SPECT using a dedicated software on vessel and participant level to lumen stenosis extent. of 50% or more in the left main coronary artery or 70% or more in any coronary artery. Classification of SDS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Difference Score (SDS) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of semi-quantitative SDS derived from static MPI SPECT using a dedicated software on vessel and participant level to FFR-CT of 0.8 or less in any coronary artery. Classification of SDS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Comparison of visual assessment of static MPI SPECT to luminal stenosis extent on coronary CTA.
Static MPI SPECT images will be evaluated by a nuclear medicine specialist. Results will be compared to luminal stenosis extent on coronary CTA. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Comparison of visual assessment of static MPI SPECT to CT-derived Fractional Flow Reserve (FFR-CT)
Static MPI SPECT images will be evaluated by a nuclear medicine specialist. Results will be compared to FFR-CT. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Models of Myocardial Flow Reserve (MFR) and Other Covariants to Coronary Artery Disease (CAD) Severity Identified by Coronary CTA
Composite endpoint:
model 1: type of chest pain, sex, age model 2: model 1 + static MPI SPECT (SSS, SRS, SDS with the following classification: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal) model 3: model 2 + MFR (expressed as a sMBF/rMBF ratio) model 4: model 3 + CACS (The following classification is used for CACS: 0, 1-9, 10-99, 100-399, 400-1000, >1000)
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Myocardial Flow Reserve (MFR) to stenosis extent on coronary CTA.
Predictive value of MFR on vessel and participant level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF) to luminal stenosis extent. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Measured: As soon as all required data is available but not later than study completion, an avarage of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start6 Mar 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Consecutive patients with suspected coronary artery disease are enrolled. Patients are referred to dynamic and static MPI using 99mTc radionuclide imaged by SPECT, following coronary CTA examination.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maurovich-Horvat Pál, Semmelweis University
- Investigators
- Pál Maurovich-Horvat, Prof. Dr., Principal investigator, Semmelweis University Medical Imaging CentreTamás Györke, MD, Study chair, Semmelweis University Department of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670768
- Sponsor's protocol ID
- OGYÉI/64876-6/2023
- Acronym
- MY-FUSION
- Status last verified
- Apr 2025
- First submitted
- 24 Oct 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A secure platform will be used to share clinical and imaging data after the results are published.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Perfusion Quantification With Single Photon Emission Computed Tomography Using Multi-Pinhole Collimator Compared to Photon-Counting Coronary Computed Tomography Angiography
- ClinicalTrials.gov ID
- NCT06670768
- Acronym / sponsor ID
- MY-FUSION / OGYÉI/64876-6/2023
- Conditions
- Coronary Artery Disease, Coronary Computed Tomography Angiography, SPECT, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
- Keywords
- Coronary Artery Disease,, Myocardial Perfusion Imaging, Myocardial Perfusion Imaging Absolute Quantification, Myocardial Flow Reserve, Plaque volume
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 1 Nov 2024 (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.
This prospective study aims to compare functional abnormalities detected using myocardial perfusion SPECT imaging (MPI SPECT) with the extent and severity of anatomical findings on coronary computed tomography angiography (coronary CTA). Additionally, the investigators aim to enhance the diagnostic value of MPI SPECT by quantifying myocardial blood flow and utilizing myocardial flow reserve calculated from dynamic SPECT images.
50 patients with suspected coronary artery disease are anticipated to be enrolled. Pharmacological stress and rest-phase dynamic and static MPI SPECT following an additional coronary CTA scan are to be performed. The obtained multimodality imaging data (functional and anatomical parameters) are planned to be compared and subjected to statistical analysis. The results of this study are expected to improve risk assessment for patients with moderate cardiovascular risk and enhance the diagnostic performance of MPI SPECT.
Detailed description
Diagnostic management of patients with moderate clinical likelihood of obstructive coronary artery disease (CAD) remains challenging. Myocardial perfusion SPECT imaging (MPI SPECT) is a widely available and cost-effective modality that provides functional information on segmental perfusion defects. However, conventional static MPI SPECT has moderate diagnostic performance in identifying subclinical coronary atherosclerosis.
The novel multi-pinhole (MPH) collimator technology with a three-detector SPECT camera (AnyScan® TRIO SPECT/CT, Mediso Ltd., Hungary) enables temporal and spatial resolution, absolute quantification of stress and rest myocardial blood flow (sMBF and rMBF), and calculated myocardial flow reserve (MFR), overcoming the difficulties of semi-quantitative evaluation.
This study aims to investigate the association between quantitative MFR, semi-quantitative functional parameters of dynamic, static MPI SPECT, and coronary CTA-based plaque metrics. Flow parameters of myocardial wall segments will be corresponded to the appropriate coronary artery based on the CT-assessed anatomy. Furthermore, the investigators aim to build statistical models representative of clinical scenarios to test the diagnostic accuracy of the MPH collimator.
In this prospective study, 50 patients with moderate cardiovascular pre-test probability (PTP) referred to either coronary CTA or MPI SPECT are anticipated to be enrolled. Cardiovascular PTP is estimated according to the CAD consortium based on age, sex, type of chest pain, and cardiovascular risk factors. Patients with a history of coronary artery bypass graft implantation, left or right bundle branch block, and atrial fibrillation will be excluded. Participants will be subjected (1) to dynamic and (2) static MPI SPECT (pharmacological stress and rest) and (3) to coronary CTA within 30 days. Patients undergoing pharmacological stress (dipyridamole or adenosine) dynamic MPI SPECT, which will be performed with AnyScan® TRIO SPECT/CT (Mediso Ltd.). Imaging will be started at the time of the radiopharmaceutical administration both in stress and rest, captured for 15 minutes in list mode. BMI-standardized doses of 99m-Tc will be used, with a same-day acquisition protocol, resulting in a three-fold increase for the rest phase compared to stress. Following each phase of dynamic acquisition in 30-60 minutes, an ECG-gated static MPI SPECT will be performed using a conventional LEHR collimator.
Data, such as sMBF, rMBF, MFR, summed stress score (SSS), summed rest score (SRS), summed difference score (SDS), as well as visually evaluated perfusion defect severity and extent will be determined from MPI SPECT. Within 30 days of MPI SPECT, coronary CTA with Calcium Score assessment will also be performed using a photon-counting detector CT (NAEOTON Alpha, Siemens Healthineers, Germany). Coronary CTA will be analyzed as follows: coronary artery calcium score (CACS), the severity of luminal stenosis, total plaque volume, quantitative plaque composition, and CT-derived fractional flow reserve (FFR). The following additional anamnestic covariants will be used: age, sex, and cardiovascular risk factors such as type of chest pain, diabetes mellitus, hypertension, smoking, obesity, and dyslipidemia.
The investigators hypothesized that dynamic MPI SPECT may prove to be superior to semi-quantitative static MPI SPECT in detecting CAD. Furthermore, MFR data combined with CACS may improve the diagnostic accuracy of MPI SPECT and guide the selection of patients for invasive coronary angiography.
MPI SPECT and coronary CTA data will be analyzed on-site at Semmelweis University, Hungary. The results will be available after the completion of patient enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive patients with suspected coronary artery disease are enrolled. Patients are referred to dynamic and static MPI using 99mTc radionuclide imaged by SPECT, following coronary CTA examination.
| Arm | Type | Receives |
|---|---|---|
| Consecutive patients with moderate pre-test probability according to CAD consortium | Experimental | Diagnostic Test: Stress Dynamic MPI SPECT, Diagnostic Test: Stress Static MPI SPECT, Diagnostic Test: Rest Dynamic MPI SPECT, Diagnostic Test: Rest Static MPI SPECT, Diagnostic Test: Cardiac CTPatients undergo dynamic and static MPI SPECT and cardiac CT within 30-days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- suspected coronary artery disease
- referred to coronary CTA or SPECT MPI by the patient's physician
- agrees to the other imaging modality that was not indicated by their physician (coronary CTA or SPECT MPI)
- suitable for informed consent
Key exclusion criteria (9 listed)
- moderate or severe aortic valve stenosis
- atrial fibrillation
- pregnancy or breastfeeding
- history of coronary artery bypass graft implantation
- history of stent implantation
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 |
|---|---|---|
| Stress Dynamic MPI SPECTBMI standardized radiopharmaceutical injection in pharmacological stress (dipyridamole or adenosine) is performed under the SPECT camera to record the temporal distribution of the activity. A one-day protocol and multi-pinhole collimator are used. | Diagnostic test | Consecutive patients with moderate pre-test probability according to CAD consortium |
| Stress Static MPI SPECT30-60 minutes after stress dynamic SPECT imaging is performed, an ECG-gated static SPECT MPI is conducted with a conventional LEHR collimator. | Diagnostic test | Consecutive patients with moderate pre-test probability according to CAD consortium |
| Rest Dynamic MPI SPECT3 hours after the stress phase, the rest phase is also recorded. A radiopharmaceutical injection with a three-fold dose at rest is performed under the SPECT camera to record the temporal distribution of the activity. A one-day protocol and multi-pinhole collimator are used. | Diagnostic test | Consecutive patients with moderate pre-test probability according to CAD consortium |
| Rest Static MPI SPECT30-60 minutes after rest, dynamic SPECT imaging is performed, and an ECG-gated static SPECT MPI is conducted with a conventional LEHR collimator. | Diagnostic test | Consecutive patients with moderate pre-test probability according to CAD consortium |
| Cardiac CTWithin 30 days of MPI SPECT imaging, a cardiac CT is performed for every patient, including a native calcium-scoring scan and a coronary CT angiography as a reference standard. A photon-counting detector CT is used. | Diagnostic test | Consecutive patients with moderate pre-test probability according to CAD consortium |
Primary outcome
The association between Myocardial Flow Reserve (MFR) and total non-calcified plaque volume as assessed by coronary CTA.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive value of MFR on vessel and participant level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF). The total non-calcified plaque volume will be measured by PCD-CT.
12 secondary outcomes
Predictive Value of Myocardial Flow Reserve (MFR) to CT-derived Fractional Flow Reserve (FFR-CT)
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of stress Myocardial Blood Flow (sMBF) to lumen stenosis extent on coronary CTA
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of stress Myocardial Blood Flow (sMBF) to CT-derived Fractional Flow Reserve (FFR-CT)
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Correlation of Myocardial Flow Reserve (MFR) and quantitative plaque composition
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Stress Score (SSS) to lumen stenosis extent on coronary CTA.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Stress Score (SSS) to CT-derived Fractional Flow Reserve (FFR-CT)
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Difference Score (SDS) to lumen stenosis extent on coronary CTA.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Difference Score (SDS) to CT-derived Fractional Flow Reserve (FFR-CT)
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Comparison of visual assessment of static MPI SPECT to luminal stenosis extent on coronary CTA.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Comparison of visual assessment of static MPI SPECT to CT-derived Fractional Flow Reserve (FFR-CT)
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Models of Myocardial Flow Reserve (MFR) and Other Covariants to Coronary Artery Disease (CAD) Severity Identified by Coronary CTA
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Myocardial Flow Reserve (MFR) to stenosis extent on coronary CTA.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. A secure platform will be used to share clinical and imaging data after the results are published.
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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.
Pál Maurovich-Horvat, Prof. Dr. principal investigator
Semmelweis University Medical Imaging Centre
Tamás Györke, MD study chair
Semmelweis University Department of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Dynamic MPI SPECT, Stress Static MPI SPECT and Rest Dynamic MPI SPECT in people with Coronary Artery Disease and Coronary Computed Tomography Angiography, run by Semmelweis University at 1 site in Hungary.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pál Maurovich-Horvat, Prof. Dr. (+36206632485, maurovich-horvat.pal@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between Myocardial Flow Reserve (MFR) and total non-calcified plaque volume as assessed by coronary CTA. (time frame: As soon as all required data is available but not later than study completion, an avarage of one year.). 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 25 Apr 2025.