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

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What is this study about?

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.

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.

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	23.01.2023

Trial locations

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.

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.

Trial ID:

2024-519979-26-00

Protocol code:

HCB.2021.1309

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?