RecruitingOBSERVATIONAL

Calcification on CTCA of a CTO and PCI Outcomes

This study is investigating a common heart condition called a Chronic Total Occlusion (CTO), which is a completely blocked heart artery. Doctors often try to open these blockages with a procedure called PCI. We know that too much calcium in the artery can make this procedure harder. This research will look back at existing CT scans (CTCA) from patients who had a CTO PCI in the last five years. By comparing the amount and location of calcium in their arteries with the success of their procedure, we hope to understand how calcium affects treatment outcomes. This information could help doctors make better decisions about how to treat patients with CTOs in the future.

At a glance

Status

Recruiting

Sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Enrolment target

100

Start

19 Jul 2024

Estimated completion

01 Jul 2025

Chronic Total Occlusion of Coronary Artery Calcification Computed Tomography Angiography

What is this study about?

Imagine the blood vessels in your heart are like pipes, carrying blood. Sometimes, one of these pipes can get completely blocked for a long time – this is called a Chronic Total Occlusion, or CTO. Doctors often try to clear these blockages using a procedure called PCI, where a tiny balloon or stent is used to open up the artery. While doctors have gotten much better at this procedure, sometimes it's still very tricky.

One thing that can make the procedure harder is a build-up of calcium in the blocked artery. It's a bit like trying to drill through a very hard, chalky patch. A special type of scan called a CT Coronary Angiography (CTCA) is very good at showing exactly where and how much calcium is in the arteries, even better than the usual X-rays used during the PCI procedure itself.

This study will look back at the medical records and scans of patients who have already had a CTO PCI procedure in the last five years. The researchers will specifically examine their CTCA scans to study the calcium in their arteries – things like where it is, how dense it is, and how much there is. Then, they will compare this information with how successful their PCI procedure was. The aim is to understand more clearly how the calcium affects the success of the procedure and if certain tools used by doctors can help overcome very calcified blockages. This could help doctors better plan and perform these important heart procedures in the future.

Key takeaways

This study looks at existing scans and records, not new treatments.
It aims to understand how calcium in blocked heart arteries affects procedure success.
No new patient involvement beyond consenting for records review.
The findings could help doctors better plan future heart procedures.
Your privacy and medical care will not be affected.

Who may be eligible?

This study is looking back at information from people who have already had a procedure to clear a completely blocked heart artery (a CTO PCI) in the last five years. You or someone you know might be included if you were at least 18 years old when you had your procedure.

Crucially, you must have also had a special type of heart scan called a CT Coronary Angiography (CTCA), either before or after your CTO PCI procedure. The images from this scan need to be clear and good enough for the researchers to study thoroughly. If you didn't have this specific CTCA scan, or if the images weren't clear, then your information wouldn't be part of this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I was 18 years old or older when I had my heart procedure.
I had a procedure to open a completely blocked heart artery (CTO PCI) in the last 5 years.
I also had a special heart scan called a CT Coronary Angiography (CTCA).
My CTCA scan images were clear and readable for doctors.

Answer every question to see your result.

What does participation involve?

If you are identified as a suitable patient based on these criteria, you will receive a phone call from the research team. They will explain the study in more detail. If you are interested, they will then mail you a consent form and a participant information sheet. These documents will provide all the details about the study. After you've had a chance to read them, if you decide you're happy to take part, you'll sign the consent form and send it back in a stamped envelope provided by the team.

Once they receive your signed form, the research team will sign it too and send a copy back to you for your records. After this, your involvement simply means that the researchers will review your existing CTCA scans and the records of your CTO PCI procedure. You won't need to attend any new appointments, have any new tests, or take any medication as part of this study. Your medical records and scans will be reviewed to gather the necessary information. The study concludes once this review is complete.

Potential risks and benefits

Because this study is looking back at existing medical records and scans, there are no direct risks to your health or safety. You will not undergo any new tests or procedures. The main benefit is that the information gathered from your records, combined with others, could help doctors better understand heart blockages with calcium and improve future treatment plans for patients with similar conditions. You have the full right to withdraw your consent at any time, even after agreeing, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Birmingham City Hospital, Sandwell and West Birmingham NHS Trust
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is a CTO PCI?

It's a procedure using a balloon and often a stent to open a heart artery that has been completely blocked for a long time.

What is a CTCA scan?

It's a special type of X-ray scan that gives very detailed pictures of your heart and blood vessels, showing any calcium build-up.

Will I have to do anything new for this study?

No, you won't need new appointments, tests, or medication. The study only uses your existing medical records and scans.

How will my information be kept private?

The researchers will follow strict rules to protect your personal information and ensure your privacy throughout the study.

What is the main goal of this research?

The goal is to understand how calcium in heart arteries affects the success of a blockage-clearing procedure, to help improve future treatments.

How to find out more

Vinoda Sharma, FRCP

vinodasharma@nhs.net +44(0)1215075841 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.