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Not yet recruitingOBSERVATIONAL

Non-invasive Detection of Coronary Artery Stenosis

This research is looking into a new, simple stick-on patch that could help detect narrowed heart arteries. These blockages are linked to a common heart condition. The patch uses tiny sensors to pick up vibrations that blood flowing through a narrowed artery can create. Scientists have tested this idea in the lab, and now they want to see if it works on real people. This study will involve a small group of healthy volunteers and patients to see if the patch can successfully spot these blockages. At this early stage, the patch won't be used to make any medical decisions, but the information gathered will help decide if this new technology is worth developing further to potentially benefit patients in the future.

At a glance

Status
Not yet recruiting
Sponsor
Nilocas
Enrolment target
20
Start
01 May 2025
Estimated completion
01 Dec 2025

What is this study about?

Imagine your heart's arteries as pipes carrying blood. Sometimes, these pipes can get a bit narrowed, which is a condition called Coronary Artery Disease. This study is testing a brand-new, simple stick-on patch designed to check for these narrowings without any invasive procedures.

The patch contains tiny sensors that can "listen" for special vibrations. When blood flows through a narrowed artery, it can create a distinctive buzz or vibration, a bit like water rushing through a tight spot in a hose. Some of these vibrations can travel through your body to your skin, and the patch aims to pick them up. This study is the very first time this patch will be used on people, and its main goal is to see if it's possible to detect these vibrations in healthy volunteers and patients with or suspected of having narrowed heart arteries. The results will be compared to existing methods like CT scans to check how well the patch performs.

It's important to understand that this is a very early-stage study. The information from the patch recordings won't be used to guide anyone's medical care during this trial. Instead, researchers simply want to find out if this new device works well enough to consider further development. If it shows promise, future, larger studies would be needed before it could ever be used in hospitals to help patients.

Key takeaways

  • This study is testing a new stick-on patch for detecting heart artery blockages.
  • It's an early-stage study, the first time tested on people.
  • The patch listens for vibrations caused by blood flow.
  • Participation involves wearing the patch; no direct health benefit from the patch itself in this study.
  • Risks are considered minimal; you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can participate. Women who could have children might be included if their doctors already planned for them to have a specific type of heart scan (coronary CT angiography).

The study is specifically looking for people who are being checked for a type of heart condition where arteries might be narrowed, but they shouldn't have other major heart problems at the same time. You also shouldn't have an infectious disease or cancer. Finally, if you're already in another medical study involving a device or medication, or have been in the last three months, you wouldn't be able to join this one.

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.

  1. Are you 18 years old or older?
  2. Are you being checked for a type of narrowed heart artery without other major heart problems?
  3. Do you currently have an infectious disease or cancer? (Must be 'No')
  4. Are you currently in another medical study for a device or drug, or have you been in the last 3 months? (Must be 'No')
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would provide written consent, meaning you understand and agree to the study. The main part involves having a prototype stick-on patch placed on your chest. This patch contains small sensors that record sounds and movements. It's battery-powered and doesn't put anything into your body. The signals from the patch are sent wirelessly to a computer for analysis. You wouldn't need any extra tests beyond what your doctors have already planned for your care. The recordings from the patch will be compared with results from a heart scan you might be already having, like a coronary CT angiography. There are no follow-up visits specifically for this study, and the duration of your participation is limited to the time the patch is recording.

Potential risks and benefits

The potential benefits of this research are not directly for you as an individual, as the patch recordings won't guide your treatment. However, your participation could help develop a new, non-invasive way to detect heart artery blockages, which might benefit many people in the future. The risks to participants are considered minimal. The device is a simple stick-on patch that doesn't interact with your body beyond listening for sounds and movements. It does not introduce any energy or substances. No specific risks or extra testing needs have been identified. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Cleveland Clinic Portland Place Outpatient Centre 24 Portland Place
    Verified postcode
    London, United Kingdom

Common questions

What is Coronary Artery Disease?

It's a common heart condition where the arteries that supply blood to your heart muscle become narrowed or blocked.

What does 'non-invasive' mean?

It means the study uses methods that don't involve breaking the skin or entering your body, like a simple stick-on patch.

Will the patch tell me if I have a blockage?

No, not in this study. The measurements are purely for research to see if the patch works. Your doctors will rely on standard tests.

Is the patch safe?

Yes, researchers believe the risk is minimal. It's a battery-powered device that just records sounds and doesn't put anything into your body.

How long will I wear the patch?

You'll wear it for a short period while the recordings are being taken, which won't be for very long.

How to find out more

Stephen E Greenwald, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Non-invasive Detection of Coronary Artery Stenosis…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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