Imaging Techniques for Angina

Overseen By Lilia Soriano, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Cardiomyopathy, Valve disease, Low eGFR, others

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

Compensation: Varies

Number of Visits: 5

Duration: 3 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors diagnose and manage INOCA, a condition where people experience chest pain (angina) without blocked heart arteries. It employs advanced imaging techniques like PET scans, CT angiograms, and functional angiography to develop a new method for identifying this condition. The trial will also determine if these imaging-guided treatments can improve symptoms and overall quality of life. Individuals who often experience chest pain or shortness of breath during physical activity but have been told their arteries aren't blocked might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to better diagnosis and treatment options for INOCA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these imaging techniques are safe for diagnosing and managing INOCA?

Research has shown that the imaging techniques used in this trial are generally safe. Studies suggest that the coronary CT angiogram is well-tolerated, with only rare, minor issues. This method primarily checks for narrow or blocked heart arteries.

Functional angiography is another method in the trial, typically used when chest pain (angina) cannot be explained by other tests. Current evidence shows it is a standard and safe way to evaluate heart function.

PET imaging is also part of the trial and is considered safe, with low radiation exposure. Most people handle it well, as the body naturally eliminates the radiation afterward.

Lastly, treadmill exercise stress tests are regularly used and considered safe for those identified as low-risk. These tests involve walking on a treadmill while monitoring heart activity.

Overall, previous studies have found these imaging methods to be safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these imaging techniques for angina because they offer a more detailed look at the heart's function and blood flow without invasive procedures. Unlike traditional methods like standard coronary angiograms, these techniques, such as coronary CT angiogram and PET imaging, provide comprehensive views of the heart's anatomy and how well it functions under stress. This could lead to earlier and more accurate diagnoses for patients experiencing angina symptoms but without obvious blockages in the arteries. By using advanced imaging, doctors hope to better understand and treat conditions like INOCA (Ischemia with Non-Obstructive Coronary Arteries), potentially leading to personalized treatment plans.

What evidence suggests that these imaging techniques are effective for diagnosing and managing INOCA?

Research has shown that Coronary CT Angiography, one of the imaging techniques studied in this trial, effectively diagnoses chest pain and can reduce the need for more invasive procedures like coronary revascularization. Studies have found this method more accurate than other tests for ruling out blocked arteries in the heart. Functional Angiography, another technique under investigation, helps identify chest pain (angina) when traditional tests don't find major artery blockages, aiding doctors in managing patients by pinpointing the exact cause of symptoms. PET imaging, also part of this trial, detects heart problems with about 90% accuracy, providing detailed information about heart disease and making it a valuable diagnostic tool. Lastly, treadmill exercise stress tests, also evaluated in this trial, are affordable and commonly used to uncover hidden heart issues, especially when other tests give false alarms. ^{2 6 7 8 9}

Who Is on the Research Team?

Krishna Patel, MBBS, MSc

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for patients with symptoms of exertional angina or shortness of breath, who have non-obstructive coronary artery disease confirmed by tests. It's not for those with severe kidney issues, certain heart conditions, pregnant women, or people unable to consent.

Inclusion Criteria

I experience chest pain or shortness of breath when I exert myself.

My heart's arteries are not severely blocked.

Exclusion Criteria

I do not have severe asthma/COPD, heart rhythm problems, or very low blood pressure.

Pregnancy

My kidney function is low, with an eGFR under 30.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo Rb-82 rest-stress myocardial perfusion imaging PET with flow quantitation and an exercise treadmill test

1-2 weeks

1 visit (in-person)

Treatment

Participants receive PET-guided management recommendations for CMD, including medication adjustments

3 months

2 visits (in-person), 1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of patient symptoms and health status

3 months

1 visit (in-person), 1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Coronary CT angiogram
• Functional Angiography
• PET imaging
• Treadmill exercise stress study

Trial Overview The study aims to develop a non-invasive method using PET scans and other imaging techniques to diagnose and manage microvascular dysfunction in patients without significant coronary artery blockages.

How Is the Trial Designed?

Group I: Patients with INOCA Experimental Treatment 4 Interventions

Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Functional imaging techniques, including Single-photon-emission computed tomography (SPECT) and stress perfusion magnetic resonance imaging, are highly accurate for detecting significant coronary artery disease (CAD) and identifying patients who may benefit from coronary revascularization.

Recent advancements in cardiac computed tomography (CT) allow for myocardial perfusion assessment (CT-MPI), showing promising diagnostic accuracy similar to traditional methods, but further studies are needed to evaluate its prognostic value and address concerns about radiation exposure and contrast agent use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT imaging of myocardial perfusion: possibilities and perspectives. Becker, A., Becker, C.[2021]

In a 2-year study involving 1266 patients, ambulatory cardiac stress testing in primary care settings was found to be safe, with no serious adverse events like heart attacks or hospitalizations reported.

The study suggests that while this testing is safe for the general population, further research is needed to assess its appropriateness for higher-risk patients and its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory cardiac single-photon emission computed tomography at the primary care physician's office: a descriptive study. Chaptini, N., Dontaraju, VS., Concepcion, F., et al.[2010]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2200963

CT or Invasive Coronary Angiography in Stable Chest Pain Computed tomography (CT) is an accurate, noninvasive alternative to invasive coronary angiography (ICA) in patients with stable chest pain and intermediate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6899446/

Guiding Therapy by Coronary CT Angiography Improves ... In patients who were not diagnosed with angina due to coronary heart disease, coronary CTA was associated with a lower primary endpoint incidence rate (0.23; 95 ...

3. insightsimaging.springeropen.com insightsimaging.springeropen.com/articles/10.1186/s13244-024-01702-y

The effectiveness of coronary computed tomography ... In patients with stable chest pain, CTA is more effective than functional testing for the diagnosis as well as for reliable exclusion of obstructive CAD.

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.123.015800

Coronary Computed Tomography Angiography Versus ... CCTA was associated with a reduction in the rates of coronary revascularization and stroke compared with direct ICA.

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(24)02679-5/fulltext

10-year outcomes from the SCOT-HEART randomised ... The SCOT-HEART trial showed that CCTA-guided management led to a reduction in the primary endpoint of coronary heart disease death or non-fatal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6201309/

Safety of Coronary CT Angiography and Functional Testing ... These data suggest that CTA and functional testing are similarly safe with only rare, and usually minor, test complications. Our findings confirm previous ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.029933

Safe Deferral of Coronary Computed Tomography ... Patients with nonobstructive or obstructive CAD have an elevated risk of adverse cardiac events. These were mainly attributable to MI and ...

8. journalofcardiovascularct.com journalofcardiovascularct.com/article/S1934-5925(22)00240-4/fulltext

CAD-RADS™ 2.0 - 2022 Coronary Artery Disease ... Coronary Artery Disease Reporting and Data System (CAD-RADS) was created to standardize reporting system for patients undergoing coronary CT ...

9. mayoclinic.org mayoclinic.org/tests-procedures/ct-coronary-angiogram/about/pac-20385117

CT coronary angiogram A CT coronary angiogram mainly is done to check for narrowed or blocked arteries in the heart. It may be done if you have symptoms of coronary artery disease.