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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

moderate or severe aortic valve stenosis

atrial fibrillation

pregnancy or breastfeeding

history of coronary artery bypass graft implantation

Trial design

Design model

Single group

Treatments tested in this trial

  • Stress Dynamic MPI SPECT

    Diagnostic 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 SPECT

    Diagnostic 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 SPECT

    Diagnostic 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 SPECT

    Diagnostic 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 CT

    Diagnostic 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Consecutive patients with moderate pre-test probability according to CAD consortiumExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
As soon as all required data is available but not later than study completion, an avarage of one year.

Secondary outcomes

1

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.

Time frame
As soon as all required data is available but not later than study completion, an avarage of one year.
2

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.

Time frame
As soon as all required data is available but not later than study completion, an avarage of one year.
3

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.

Time frame
As soon as all required data is available but not later than study completion, an avarage of one year.
4

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.

Time frame
As soon as all required data is available but not later than study completion, an avarage of one year.

Other outcomes

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