CT vs PET Scans for Coronary Artery Disease

Overseen By Carlo De Cecco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Metformin

Disqualifiers: Pregnancy, Implanted devices, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare different heart imaging techniques to determine which best assesses blood flow in the heart. It will test CT-MPI and CT-FFR against the standard PET-MPI to identify the most accurate method for evaluating coronary artery disease. Individuals referred for a heart imaging test to check for coronary artery disease, and who are not taking certain medications, might be suitable candidates for this trial. As an unphased trial, it offers participants the opportunity to contribute to the advancement of heart imaging techniques.

Will I have to stop taking my current medications?

If you are taking any medications containing metformin, you will need to stop taking them at least 48 hours before participating in the trial.

What prior data suggests that these imaging techniques are safe for coronary artery disease?

Research shows that the treatments used in this study—CT-FFR, CT-MPI, and PET-MPI—are generally safe for people.

CT-FFR is a non-invasive method to check blood flow in the heart. Studies have successfully used it to assess coronary artery disease (heart disease caused by narrowed arteries) without major safety concerns.

CT-MPI is a newer technique that measures how well blood moves through the heart muscle. Research has shown it is safe and uses a low dose of radiation, which benefits health.

PET-MPI is well-established and has a long history of safety. It is often used to evaluate blood flow in the heart. Studies have confirmed its safety and reliability for diagnosing heart problems.

Overall, these imaging methods are considered well-tolerated, with no significant adverse effects reported. They provide non-invasive ways to learn more about heart health, making them a safer choice for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing CT and PET scan techniques for diagnosing coronary artery disease because each method offers unique insights into heart health. Unlike traditional stress tests or standard imaging, CT-FFR (Fractional Flow Reserve) provides a non-invasive way to assess blood flow and pinpoint blockages in coronary arteries. CT-MPI (Myocardial Perfusion Imaging) and PET-MPI offer detailed pictures of how well blood is reaching the heart muscle, which could improve how accurately doctors diagnose and manage heart conditions. By exploring these advanced imaging techniques, researchers hope to refine diagnostic precision and ultimately enhance patient care for those with coronary artery disease.

What evidence suggests that this trial's imaging techniques could be effective for coronary artery disease?

This trial will compare three imaging techniques: CT-FFR, CT-MPI, and PET-MPI. Studies have shown that CT-FFR effectively rules out serious heart artery disease, correctly identifying its absence 99% of the time and achieving a 97% accuracy rate in confirmation. CT-MPI is promising because it accurately measures blood flow in the heart, aiding in the detection of blockages. Research indicates that patients using CT-MPI underwent fewer invasive procedures, such as coronary angiography, within 90 days. PET-MPI excels at detecting heart artery disease, helping to avoid unnecessary invasive procedures and reducing costs. Overall, all three imaging methods effectively assess heart health, each with strengths in different areas. Participants in this trial will undergo all three imaging techniques for a comprehensive analysis of myocardial perfusion. ^{6 7 8 9 10}

Who Is on the Research Team?

Carlo De Cecco, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for individuals who need a CT scan to check for coronary artery disease and are willing to follow the study's procedures. They must not be pregnant, nursing, or have taken certain diabetes medications recently. People with implanted heart devices, severe allergies to contrast material used in scans, kidney issues, low blood pressure, or specific heart rhythm problems cannot participate.

Inclusion Criteria

Must be willing to comply with all clinical study procedures

Must provide written informed consent prior to any study-related procedures being performed

I am referred for a CT scan to check my heart's blood flow.

Exclusion Criteria

Pregnant or nursing females

Currently taking or has taken within 48 hours the following excluded medications: ActoPlus Met (Pioglitazone + metformin), Avandamet (Rosiglitazone + metformin), Fortamet (metformin), Glucovance (Glyburide +metformin), Glucophage (metformin), Glucophage extended-release (XR) (metformin), Glumetza (metformin), Janumet (Sitagliptin + metformin), Metformin, Metaglip (Glipizide + metformin), Riomet (metformin), Implanted rhythm devices (pacemaker, defibrillator), Acute psychiatric disorder, Unwilling to comply with the requirements of the protocol, Previously entered this study, Known hypersensitivity to iodinated contrast material, beta-blockers, or pharmaceutical stressors used in this study, Suffers from claustrophobia, Impaired renal function (GFR < 45 ml/min), Acute hypotension (<100 mm Hg systolic), 2nd or 3rd degree atrioventricular (AV) block

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Analysis

Participants undergo PET-MPI, CT-MPI, and CT-FFR imaging for analysis of myocardial perfusion and coronary flow

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT-FFR
• CT-MPI
• PET-MPI Protocol
• Regadenoson

Trial Overview The MATCH Investigation aims to compare two types of heart imaging tests: CT scans that measure blood flow and blockages in the heart arteries (CT-MPI and CT-FFR) against PET scans known as PET-MPI which is considered the gold standard.

How Is the Trial Designed?

Group I: Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR Experimental Treatment 4 Interventions

Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Siemens Medical Solutions

Industry Sponsor

Trials

26

Recruited

6,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12383964/

Clinical Impact of CT-Based FFR in Everyday Cardiology In the past decade, the use of FFRCT, combined with advanced computational analysis, has significantly improved the non-invasive assessment of ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.034552

Agreement of Fractional Flow Reserve Estimated by ... Fractional flow reserve‐computed tomography (FFR‐CT) can rule out hemodynamically significant coronary artery disease when FFR‐CT is >0.90 with ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233354

Clinical Effectiveness of Automated Coronary CT-derived ... CT-FFR added to CCTA led to a lower 90-day ICA rate and similar 1-year MACE rate in a Chinese real-world setting.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12386757/

Fractional Flow Reserve from Coronary CT - PubMed Central CCTA has a sensitivity of up to 99% and a negative predictive value of 97%, making it highly effective for excluding significant coronary artery ...

5. jacc.org jacc.org/doi/10.1016/j.jcmg.2023.02.005

The Use and Efficacy of FFR-CT: Real-World Multicenter ... In our audit, patients with FFR-CT of >0.80 had a 1.9% rate of nonfatal MI or death at a mean follow-up of 17 months, similar to those with FFR- ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.037988

Prognostic Significance of Computed Tomography ... Data on the predictive value of coronary computed tomography angiography–derived fractional flow reserve (CT‐FFR) for long‐term outcomes are ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12516765/

Coronary Computed Tomography Angiography-Derived ... For CAD-RADS 2 with proximal ≥ 40% stenosis, CT-FFR may be considered to assess the hemodynamic significance even with high-risk plaque features ...

8. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=38839

Non-Invasive Fractional Flow Reserve (FFR) for Ischemic ... Use this page to view details for the Local Coverage Determination for Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease.

9. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.210097

CT Fractional Flow Reserve: A Practical Guide to ... CT fractional flow reserve (FFR CT) is a physiologic simulation technique that models coronary flow from routine coronary CT angiography (CTA).

10. journalofcardiovascularct.com journalofcardiovascularct.com/article/S1934-5925(25)00345-4/fulltext

CT derived fractional flow reserve: Part 2 Coronary computed tomography (CCTA) is a well-established noninvasive test for the evaluation of patients with suspected coronary artery disease (CAD). The ...