Myocardial Perfusion Quantification With SPECT Using Multi-Pinhole Collimator Compared to Photon-Counting Coronary CTA
NCT ID: NCT06670768
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-06
2026-08-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Consecutive patients with moderate pre-test probability according to CAD consortium
Patients undergo dynamic and static MPI SPECT and cardiac CT within 30-days.
Stress Dynamic MPI SPECT
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 SPECT
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 SPECT
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 SPECT
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 CT
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.
Interventions
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Stress Dynamic MPI SPECT
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 SPECT
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 SPECT
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 SPECT
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 CT
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* atrial fibrillation
* pregnancy or breastfeeding
* history of coronary artery bypass graft implantation
* history of stent implantation
* chronic renal failure (eGFR \< 30 ml/m2)
* active oncological treatment
* congenital heart disease
* left or right bundle branch block
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Prof. Maurovich-Horvat Pál
Head of Clinic for Medical Imaging
Principal Investigators
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Pál Maurovich-Horvat, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University Medical Imaging Centre
Tamás Györke, MD
Role: STUDY_CHAIR
Semmelweis University Department of Nuclear Medicine
Locations
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Semmelweis University, Medical Imaging Centre
Budapest, Budapest, Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OGYÉI/64876-6/2023
Identifier Type: -
Identifier Source: org_study_id
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