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Study on Theophylline, Gadoteric Acid, and Regadenoson for Patients with Chronic Total Coronary Artery Blockage

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying patients with coronary artery chronic total occlusion, a condition where a coronary artery is completely blocked for a long period. The study aims to evaluate the effectiveness of different imaging techniques in detecting heart muscle health and blood flow issues in these patients. The imaging methods being used include coronary CT angiography, myocardial perfusion imaging, and stress cardiac MRI. These techniques help doctors see how well blood is flowing to the heart and if there are any areas of the heart muscle that are not getting enough blood.

During the study, participants will receive injections of different substances to help with imaging. These include theophylline anhydrous, which is used to help open up the airways in the lungs, gadoteric acid, a contrast agent that helps make blood vessels and tissues more visible on MRI scans, and regadenoson, a medication that helps to widen the blood vessels of the heart. The study will compare the results of these imaging techniques to see how well they can detect areas of the heart that are not getting enough blood or have been damaged.

The purpose of this study is to improve the understanding of how these imaging techniques can be used to assess heart health in patients with chronic total occlusion. Participants will undergo these imaging tests at the beginning of the study and again after six months. The study will also monitor for any side effects or adverse events that may occur during the imaging procedures. This research aims to provide valuable information that could help improve the diagnosis and treatment of patients with this heart condition in the future.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying a chronic total occlusion in a native coronary artery, ensuring the patient is 18 years or older, and confirming the ability to provide informed consent.
Step 2
Baseline cardiac magnetic resonance imaging (CMR)
A baseline cardiac magnetic resonance imaging (CMR) study will be performed. This imaging will be conducted on a 3T system to assess the heart's structure and function.
Step 3
Computed tomography (CT) study
A computed tomography (CT) study will be performed as part of the pre-procedural evaluation. This includes a static perfusion assessment at stress and rest, coronary angiography, and late enhancement for viability evaluation using a dual-source scanner.
Step 4
Administration of medications
During the trial, the following medications will be administered intravenously as solutions for injection:
Eufilina Venosa (200 mg) containing theophylline anhydrous.
Clariscan (0.5 mmol/mL) containing gadoteric acid.
Rapiscan (400 microgram) containing regadenoson.
Step 5
Follow-up cardiac magnetic resonance imaging (CMR)
A follow-up cardiac magnetic resonance imaging (CMR) study will be conducted 6 months after the intervention to evaluate changes in the heart's structure and function.
Step 6
Invasive physiological assessment
An invasive physiological assessment will be performed to optimize percutaneous treatment. This includes follow-up catheterization in patients with significant distal stenosis.
Step 7
Evaluation of adverse events
Throughout the trial, any adverse events will be monitored and evaluated according to the definitions provided by the Chronic Total Occlusion Academic Research Consortium.
Step 8
Completion of trial
The trial is estimated to conclude by December 1, 2025. At this point, all data will be analyzed to evaluate the study's objectives.

Who can join the trial?

5 criteria

Have a chronic total occlusion in a native coronary artery. This means there is a complete blockage in one of the heart's main blood vessels.
Be 18 years or older.
The blood vessel beyond the blockage should have a diameter of at least 2.5 mm.
Be able to provide informed consent, which means you understand the study and agree to participate.
Be willing to follow the study's follow-up protocol, which involves attending scheduled appointments and tests.

Who cannot join the trial?

4 criteria

Patients who have a different heart condition than the one being studied, which is a chronic total occlusion of the coronary artery. This means a complete blockage in one of the heart's arteries.
Patients who are not within the specified age range for the study.
Patients who belong to a group that is not included in the study.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

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Hospital Clinic De Barcelona
Verified
Barcelona, Spain

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Investigated drugs

Coronary CT Angiography
is a non-invasive imaging test that uses X-rays to create detailed pictures of the heart's blood vessels. In this trial, it is used to evaluate the blood flow in patients with blocked coronary arteries.
Myocardial Perfusion Imaging
is a type of nuclear medicine procedure that illustrates the function of the heart muscle. It is performed both at rest and under stress to assess how well blood flows through the heart muscle and to detect areas with reduced blood flow.
Stress Cardiac MRI
is a test that uses magnetic fields and radio waves to create detailed images of the heart. It is performed while the heart is under stress to evaluate the heart's structure and function, helping to identify areas of the heart muscle that may not be receiving enough blood.

What is already known about the treatment

Coronary CT Angiography – This imaging technique is administered non-invasively through a CT scan, which involves the use of X-rays to create detailed images of the coronary arteries. It is currently well-established in medical practice and literature for evaluating coronary artery disease. The main therapeutic indication is to assess coronary artery chronic total occlusion. At the molecular level, it works by providing high-resolution images that help visualize the blood flow and detect blockages in the coronary arteries. It is classified under diagnostic imaging techniques in pharmacology.

Investigated diseases

Coronary Artery Chronic Total Occlusion – This condition occurs when a coronary artery is completely blocked for a prolonged period, typically over three months. The blockage prevents normal blood flow through the artery, which can lead to reduced oxygen supply to the heart muscle. Over time, the heart may develop alternative pathways, known as collateral circulation, to bypass the blockage. However, these pathways may not be sufficient to meet the heart's oxygen demands, especially during physical exertion. The condition can result in symptoms such as chest pain or discomfort, particularly during activities that increase the heart's workload. Chronic total occlusion is often identified through imaging techniques that assess blood flow and heart muscle viability.