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Идёт набор NCT06670768

Myocardial Perfusion Quantification With SPECT Using Multi-Pinhole Collimator Compared to Photon-Counting Coronary CTA

Без фазы С лечением Coronary Artery Disease Coronary Computed Tomography Angiography SPECT Heart Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Stress Dynamic MPI SPECT, Stress Static MPI SPECT, Rest Dynamic MPI SPECT, Rest Static MPI SPECT.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease, Coronary Computed Tomography Angiography, SPECT, Heart Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Венгрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Myocardial Perfusion Quantification With Single Photon Emission Computed Tomography Using Multi-Pinhole Collimator Compared to Photon-Counting Coronary Computed Tomography Angiography

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.
  • Диагностический тест 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.
  • Диагностический тест 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.
  • Диагностический тест 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.
  • Диагностический тест 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.

Первичные конечные точки

  • The association between Myocardial Flow Reserve (MFR) and total non-calcified plaque volume as assessed by coronary CTA. [Срок оценки: As soon as all required data is available but not later than study completion, an avarage of one year.]
Вторичные конечные точки (12)
  • Predictive Value of Myocardial Flow Reserve (MFR) to CT-derived Fractional Flow Reserve (FFR-CT) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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) [Срок оценки: 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. [Срок оценки: 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) [Срок оценки: 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. [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: As soon as all required data is available but not later than study completion, an avarage of one year.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)
  • active oncological treatment
  • congenital heart disease
  • left or right bundle branch block

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Венгрия · 1 центр
  • Semmelweis University, Medical Imaging Centre — Budapest

Идентификаторы

NCT: NCT06670768 · OGYÉI/64876-6/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗