Chronic disease Trials in Disease

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

This clinical trial is being conducted in Spain and focuses on patients with coronary artery chronic total occlusion. This is a serious condition where one of the heart's main blood vessels has been completely blocked for a long period, typically over three months. When this happens, the heart muscle may not receive enough oxygen-rich blood, especially during physical activity, which can cause chest pain or discomfort.

Who can participate?

To be eligible for this study, participants must meet the following criteria:

• Have a chronic total occlusion in a native coronary artery, meaning there is a complete blockage in one of the heart's main blood vessels
• Be 18 years of age or older
• Have a blood vessel beyond the blockage with a diameter of at least 2.5 mm
• Be able to understand the study and provide informed consent
• Be willing to attend scheduled follow-up appointments and tests

Who cannot participate?

Patients will be excluded from this study if they:

• Have a different heart condition than the chronic total occlusion being studied
• Are not within the specified age range
• Belong to vulnerable populations that the study does not include

What is the study about?

The main goal of this trial is to evaluate how well different imaging techniques can detect problems with heart muscle health and blood flow in patients with this type of blockage. The heart may develop alternative pathways called collateral circulation to work around the blockage, but these may not be sufficient to supply enough oxygen to the heart, particularly during exercise.

The study uses three main imaging methods:

• Coronary CT angiography – a non-invasive test using X-rays to create detailed pictures of the heart's blood vessels
• Myocardial perfusion imaging – a nuclear medicine procedure that shows how well blood flows through the heart muscle, performed both at rest and under stress
• Stress cardiac MRI – a test using magnetic fields and radio waves to create detailed images of the heart while it is under stress

Participants will undergo these imaging tests at the beginning of the study and again after six months. The results will be compared to see which techniques best detect areas of the heart that are not receiving enough blood or have been damaged.

What medications are used?

During the imaging procedures, participants will receive injections of three different substances to help with the imaging:

• Theophylline anhydrous (Eufilina Venosa, 200 mg) – helps open airways and improve imaging quality
• Gadoteric acid (Clariscan, 0.5 mmol/mL) – a contrast agent that makes blood vessels and tissues more visible on MRI scans
• Regadenoson (Rapiscan, 400 micrograms) – a medication that helps widen the blood vessels of the heart during stress testing

All medications are given intravenously as solutions for injection.

What happens during the study?

After the initial assessment confirms eligibility, participants will undergo baseline imaging with cardiac MRI and CT scans. These tests provide detailed information about the heart's structure, function, and blood flow. An invasive physiological assessment may also be performed to optimize treatment decisions. Throughout the trial, any side effects or adverse events will be carefully monitored. A follow-up cardiac MRI will be conducted six months after the intervention to evaluate any changes in the heart's condition. The trial is expected to conclude by December 2025.

This research aims to improve understanding of how these advanced imaging techniques can be used to assess heart health in patients with chronic total occlusion, potentially leading to better diagnosis and treatment strategies in the future.