Cardiac MRI Technique for Coronary Artery Disease

(CATCH Trial)

Overseen By Debiao Li, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Cardiovascular disease, Implants, Pregnancy, Claustrophobia, Renal issues, others

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

Compensation: Varies

Number of Visits: 1

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug for coronary artery disease?

Beta-blockers like carvedilol, bisoprolol, and metoprolol have been shown to improve heart function and survival in patients with heart failure, which suggests they may also help in managing coronary artery disease by improving heart health. ^{1 2 3 4 5}

Are beta-blockers safe for humans?

Beta-blockers, like carvedilol, metoprolol, and bisoprolol, have been shown to improve survival and symptoms in heart failure patients, indicating they are generally safe for human use. However, they may have different effects and tolerability, so it's important to discuss with a doctor which one is best for you. ^{1 5 6 7 8}

How does cardiac MRI differ from other treatments for coronary artery disease?

Cardiac MRI is unique because it is a noninvasive imaging technique that provides detailed information about the heart's structure and function, helping to detect and assess coronary artery disease without the need for invasive procedures. It uses magnetic fields and contrast agents to visualize blood flow and heart tissue, offering precise measurements and the ability to differentiate between types of heart damage. ^{9 10 11 12 13}

Research Team

Debiao Li, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

The CATCH trial is for adults over 18 with a BMI under 30, who are either healthy volunteers without cardiovascular disease or patients stable after coronary artery disease diagnosis and treatment. It excludes those with MR imaging contraindications like certain implants, claustrophobia, severe allergies to animal dander, poor kidney function (GFR <45ml/min), or past reactions to gadolinium contrast.

Inclusion Criteria

Healthy volunteers who are 18 years or older, not overweight, and have no history of heart problems.

You are a man or woman over 18 years old and do not have suspected or diagnosed heart artery problems with stenting or bypass surgery.

Exclusion Criteria

Non-compliant with visit instructions, including following procedure instructions

You cannot have metal implants or be pregnant because they can interfere with the MRI scan.

You cannot hold your breath for a short time or have a fear of small, enclosed spaces.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo non-contrast or contrast-enhanced MRI to evaluate coronary atherosclerosis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2-4 weeks

Treatment Details

Interventions

• Beta blocker
• Cardiac MRI
• Contrast

Trial Overview CATCH aims to develop an MRI technique that enhances the evaluation of coronary atherosclerosis. The study will test this new method against traditional ones by comparing image quality and scanning efficiency. Participants may receive cardiac MRI scans using contrast agents and possibly beta blockers during the procedure.

Participant Groups

Group I: Healthy Volunteers Experimental Treatment 3 Interventions

Approximately 100 healthy male/female adult "normals" or "controls" will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.

Group II: Coronary Artery Disease (CAD) Patients Experimental Treatment 3 Interventions

40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease (CAD) will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

Only three beta-blockers—carvedilol, bisoprolol, and metoprolol succinate—have shown positive effects on prognosis in chronic heart failure patients, highlighting their importance in treatment.

Carvedilol not only blocks beta(1)-adrenergic receptors but also beta(2)- and alpha(1)-adrenergic receptors, and has additional properties that may contribute to its superior mortality reduction compared to metoprolol, as demonstrated in the COMET trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beta-blockers in heart failure: are pharmacological differences clinically important? Metra, M., Cas, LD., di Lenarda, A., et al.[2018]

In a study of 70 patients with chronic heart failure, both nebivolol and carvedilol improved left ventricular function, with increases in ejection fraction and decreases in end-systolic volume after 6 months of treatment, although the differences between the two drugs were not statistically significant.

Both medications resulted in a significant reduction in heart rate and blood pressure, and there were no significant differences in adverse events, indicating that nebivolol is as safe and effective as carvedilol for treating patients with reduced left ventricular systolic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nebivolol versus carvedilol on left ventricular function in patients with chronic heart failure and reduced left ventricular systolic function. Lombardo, RM., Reina, C., Abrignani, MG., et al.[2018]

In a study of 160 hypertensive patients with chronic heart failure over 24 months, both nebivolol and carvedilol significantly improved left ventricular ejection fraction (LVEF) and exercise capacity, showing similar efficacy in treatment.

Both medications led to a reduction in heart rate and improvement in functional class, with comparable rates of cardiac events, indicating that nebivolol and carvedilol are equally effective options for managing chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative long term effects of nebivolol and carvedilol in hypertensive heart failure patients. Marazzi, G., Volterrani, M., Caminiti, G., et al.[2018]

Beta-adrenergic receptor blockers, such as bisoprolol, metoprolol, and carvedilol, have been proven to significantly improve survival rates and reduce hospitalization in heart failure patients, leading to better overall patient well-being.

While investigational beta-blocker bucindolol showed only mild improvements in survival, the differences in properties among beta-blockers, such as selectivity and vasodilation effects, remain to be fully understood in terms of their impact on treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are all beta-blockers the same for chronic heart failure? Gottlieb, SS.[2019]

Beta-blockers are effective in treating various cardiovascular diseases, showing positive outcomes in reducing mortality for conditions like hypertension, post-infarction recovery, and heart failure, particularly with drugs like carvedilol, bisoprolol, and metoprolol.

Recent evidence highlights the life-prolonging benefits of beta-blockers in heart failure, especially in patients classified as NYHA stages 2 and 3, while the presence of intrinsic sympathomimetic activity (ISA) in some beta-blockers, like bucindolol, may limit their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison beta-blockers and their relevance to pharmacologic therapy of cardiovascular diseases]. Wehling, M.[2007]

In a study of 29 heart failure patients, replacing carvedilol with propranolol did not worsen heart function, as measured by ejection fraction, after 6 months, indicating that propranolol can be a safe alternative.

The study found that propranolol led to a significant increase in ejection fraction, suggesting it may be effective in improving heart function in patients previously stabilized on carvedilol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacement of carvedilol for propranolol in patients with heart failure. Marques, F., Castro, RB., Nobre, F., et al.[2019]

Beta-blockers are effective treatments for various cardiovascular conditions, but they are often underprescribed due to concerns about safety and tolerability, especially in high-risk populations.

Newer beta-blockers like nebivolol and carvedilol offer additional benefits, such as vasodilation and improved insulin resistance, which may enhance their efficacy and reduce side effects compared to older, nonselective beta-blockers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realities of newer beta-blockers for the management of hypertension. Manrique, C., Giles, TD., Ferdinand, KC., et al.[2021]

In a study of 20 patients with systolic heart failure, nebivolol was found to improve hemodynamic parameters by decreasing systemic vascular resistance without negatively affecting cardiac output, unlike metoprolol, which worsened heart function.

The results suggest that nebivolol may be a safer option for initiating treatment in systolic heart failure patients, as it does not require a long up-titration period to avoid adverse effects seen with metoprolol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of moderate doses of nebivolol versus metoprolol in patients with systolic heart failure. Triposkiadis, F., Giamouzis, G., Kelepeshis, G., et al.[2019]

Cardiovascular MRI is a safe and highly effective imaging technique that provides detailed anatomical and functional information about the heart, making it the best choice for measuring changes in heart function after treatment.

It is particularly useful for diagnosing various heart conditions, including ischemic and nonischemic cardiomyopathies, and is emerging as a reliable alternative to traditional methods for detecting coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of cardiovascular magnetic resonance imaging. Marcu, CB., Beek, AM., van Rossum, AC.[2018]

Magnetic resonance imaging (MRI) is increasingly used for cardiac diagnosis, particularly with the help of paramagnetic contrast agents that enhance the visibility of heart conditions.

Contrast-enhanced MRI can effectively detect and characterize various cardiac issues, such as intracardiac masses, thrombi, and myocarditis, and is also useful in diagnosing myocardial ischemia and infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced MR imaging of the heart: overview of the literature. Edelman, RR.[2007]

Cardiovascular magnetic resonance imaging (MRI) has advanced significantly, transitioning from an experimental technique to a clinically accepted method for detecting coronary artery disease and assessing heart viability.

Current MRI technologies, including dobutamine/atropine MRI and perfusion techniques, are effective for evaluating ischemia and blood flow in both native coronary arteries and grafts, suggesting a promising future for widespread clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in detection and functional assessment of coronary artery disease. Mazur, W., Brucks, S., Darty, SN., et al.[2019]

Cardiac magnetic resonance (CMR) imaging is a powerful noninvasive tool that can assess both the function and structure of the heart, as well as evaluate the severity and reversibility of coronary heart disease.

Recent advancements in technology, such as improved magnet and coil designs and new contrast media, have enhanced the effectiveness of CMR, making it a versatile option for diagnosing and managing coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of myocardial ischemia and viability using cardiac magnetic resonance. Sanz, J., Rius, T., Kuschnir, P., et al.[2019]

Cardiac magnetic resonance imaging (CMR) is now considered the gold standard for diagnosing coronary artery disease and acute myocardial infarction, effectively distinguishing between ischemic and non-ischemic heart injuries.

CMR is recognized for its safety and is indicated for various cardiac assessments, although there are specific contraindications that must be considered before use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of cardiac magnetic resonance imaging (cardiovascular magnetic resonance) in defining the prognosis of patients with acute ST-segment elevation myocardial infarction. Part 1. Indications and contraindications to cardiovascular magnetic resonance]. Terenicheva, MA., Stukalova, OV., Shakhnovich, RM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Beta-blockers in heart failure: are pharmacological differences clinically important? [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of nebivolol versus carvedilol on left ventricular function in patients with chronic heart failure and reduced left ventricular systolic function. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative long term effects of nebivolol and carvedilol in hypertensive heart failure patients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Are all beta-blockers the same for chronic heart failure? [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Comparison beta-blockers and their relevance to pharmacologic therapy of cardiovascular diseases]. [2007]

6. Brazil pubmed.ncbi.nlm.nih.gov

Replacement of carvedilol for propranolol in patients with heart failure. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Realities of newer beta-blockers for the management of hypertension. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of moderate doses of nebivolol versus metoprolol in patients with systolic heart failure. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Clinical applications of cardiovascular magnetic resonance imaging. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Contrast-enhanced MR imaging of the heart: overview of the literature. [2007]

11. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in detection and functional assessment of coronary artery disease. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Assessment of myocardial ischemia and viability using cardiac magnetic resonance. [2019]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The role of cardiac magnetic resonance imaging (cardiovascular magnetic resonance) in defining the prognosis of patients with acute ST-segment elevation myocardial infarction. Part 1. Indications and contraindications to cardiovascular magnetic resonance]. [2022]