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

NCT06670768 | Recruiting DMC

• 1 other identifier: OGYÉI/64876-6/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease; Coronary Computed Tomography Angiography; SPECT; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Myocardial Ischemia; Coronary Disease; Chest Pain

Keywords

Coronary Artery Disease,; Myocardial Perfusion Imaging; Myocardial Perfusion Imaging Absolute Quantification; Myocardial Flow Reserve; Plaque volume

Outcome Measures

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.

  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)

  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

  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)

  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

  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.

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

Study Arms (1)

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.

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

Interventions

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.

Consecutive patients with moderate pre-test probability according to CAD consortium

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.

Consecutive patients with moderate pre-test probability according to CAD consortium

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.

Consecutive patients with moderate pre-test probability according to CAD consortium

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.

Consecutive patients with moderate pre-test probability according to CAD consortium

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.

Consecutive patients with moderate pre-test probability according to CAD consortium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Medical Imaging Centre

Budapest, Budapest, 1083, Hungary

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Myocardial Ischemia; Coronary Disease; Chest Pain

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pál Maurovich-Horvat, Prof. Dr.

  Semmelweis University Medical Imaging Centre

  PRINCIPAL INVESTIGATOR

• Tamás Györke, MD

  Semmelweis University Department of Nuclear Medicine

  STUDY CHAIR

Central Study Contacts

Pál Maurovich-Horvat, Prof. Dr.

CONTACT

+36206632485; maurovich-horvat.pal@semmelweis.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic for Medical Imaging

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 1, 2024
• Study Start: March 6, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Clinical and imaging data will be available after the results have been published.
• Access Criteria: Access request needs to be made directly to the PI.

Locations

HU (1)