Active not recruitingNAINTERVENTIONAL

COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events

This study, called COMBINE-INTERVENE, is investigating a new approach to treating heart artery disease. People with multiple narrowed arteries will be involved. The researchers want to find out if using a combination of two special tests to guide treatment is better than using just one. One test measures blood flow (FFR) and the other takes detailed pictures inside the arteries (OCT) to spot 'vulnerable plaques' – areas that might be more likely to cause future problems. By carefully comparing these two approaches, the study hopes to discover a more effective way to prevent heart issues like heart attacks in the future. It's about finding the best way to decide exactly where and how to treat your arteries.

At a glance

Status

Active not recruiting

Phase

Sponsor

Diagram B.V.

Enrolment target

1,223

Start

16 Mar 2022

Estimated completion

31 Dec 2026

Multivessel Coronary Artery Disease Ischemia Vulnerable Plaque Coronary Artery Disease

What is this study about?

Imagine your heart's arteries are like pipes carrying blood. Sometimes, these pipes get narrowed or blocked by fatty deposits, which can lead to heart problems. Doctors often treat this by inserting small tubes called stents to keep the arteries open. This study is looking at the best way to decide exactly where to put these stents and how best to treat these narrowed areas.

Traditionally, doctors have looked at how much blood flow is affected by a narrowing. If the blood flow is significantly reduced, they might decide to place a stent. This study is exploring if it's better to also look closely at the type of narrowing itself. Some fatty deposits, called 'vulnerable plaques,' might be more likely to cause trouble in the future, even if they aren't severely limiting blood flow right now. Advanced scanning techniques can help spot these vulnerable areas.

The COMBINE-INTERVENE study wants to see if combining both methods – looking at blood flow and also scanning for these vulnerable plaques – will lead to better results for patients. They will compare this combined approach with the current method of only focusing on blood flow. The goal is to figure out if being more precise about where and how to treat these artery problems can help patients stay healthier and prevent future heart events.

Key takeaways

This study compares two ways of deciding how to treat narrowed heart arteries with stents.
It investigates if combining blood flow measurement and detailed artery scans is better than just blood flow measurement.
The goal is to find a more effective way to prevent future heart problems.
It's for people with multiple narrowed heart arteries who are having a PCI procedure.
Participants must be between 30 and 80 years old and meet specific health criteria.
The study aims to improve understanding of treating 'vulnerable plaques' in arteries.

Who may be eligible?

To be considered for this study, you would generally need to be between 30 and 80 years old and undergoing a procedure to treat narrowed heart arteries (PCI). Your medical team would need to identify at least two narrowed areas in different main heart arteries that they believe can be safely treated with this procedure.

There are also some specific requirements for these narrowed areas themselves: they need to be a certain size, in a natural artery (not a bypass graft), and not completely blocked. The blood flow through your arteries should be good, unless the narrowing is the direct cause of a recent heart attack.

However, some conditions would mean you couldn't join the study. These include if you need a different type of heart surgery (like a bypass), if the narrowed areas are in certain complex parts of the heart, or if you have very severe kidney or heart valve problems. Also, if the doctors think the study procedures would be too risky for you, or if your life expectancy is less than three years, you would not be eligible.

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.

Are you between 30 and 80 years old?
Are you having a procedure to open up narrowed heart arteries (PCI)?
Do you have at least two narrowed areas in different main heart arteries that your doctor thinks can be treated?
Do you have good kidney function and generally good heart muscle strength?
Do you not need a different major heart operation (like bypass surgery)?
Do you not have certain complex heart conditions or severe valve problems?

Answer every question to see your result.

What does participation involve?

The information provided does not detail the specific schedule of visits, assessments, medication, or the total duration of the follow-up for participants joining the COMBINE-INTERVENE study. Typically, studies like this involve an initial screening to confirm you meet the eligibility criteria, followed by the planned treatment procedure. You would likely have regular follow-up appointments, which may include physical examinations, blood tests, and heart scans for a set period, possibly several months or even years, to monitor your health and the effectiveness of the treatment. Any specific medications would be discussed with you by the study team, and you would be informed about how often you need to attend clinic visits or undergo tests.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a cutting-edge approach to treating your heart arteries that might lead to better long-term outcomes. However, as with any medical procedure, there are potential risks involved with the diagnostic tests and treatments, which your doctor will explain fully. These could include risks associated with heart procedures themselves, though the study aims to use established methods in a new way. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

Monash Medical
Verified postcode
Clayton, Australia
Hamilton Health Sciences
Verified postcode
Hamilton, Canada
McGill University Health Centre
Verified postcode
Montreal, Canada
Niagara Health System - St. Catherines Site
City only
Saint Catharines, Canada
Aarhus University Hospital
Verified postcode
Aarhus, Denmark
North-Estonia Medical Centre
Verified postcode
Tallinn, Estonia
Centre Hospitalier Régional Universitaire de Lille
Verified postcode
Lille, France
Clinique Louis Pasteur
Verified postcode
Nancy, France
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany
Universitätsklinikum Frankfurt
Verified postcode
Frankfurt, Germany
Apex Heart Institute
Verified postcode
Ahmedabad, India
Apollo Hospitals
Verified postcode
Bangalore, India

Common questions

What is 'PCI'?

PCI stands for Percutaneous Coronary Intervention. It's a procedure where doctors use a tiny balloon and usually a small mesh tube called a stent to open up narrowed or blocked heart arteries and improve blood flow.

What is 'vulnerable plaque'?

Vulnerable plaque refers to fatty deposits in your arteries that are thought to be more unstable and more likely to rupture, potentially leading to a blood clot and a heart attack, even if they aren't severely blocking blood flow right now.

What does 'FFR' and 'OCT' mean?

FFR (Fractional Flow Reserve) is a measurement that checks how well blood flows through a narrowed artery. OCT (Optical Coherence Tomography) is an advanced imaging technique that gives doctors very detailed pictures from inside your arteries to see the structure of any fatty deposits.

Why is this study important?

This study is important because it's trying to find the best way to decide where and how to treat narrowed heart arteries. It compares different methods of guiding treatment to see if a more detailed assessment can lead to better long-term heart health for patients.

Will I know which treatment I receive?

Clinical trials often assign participants to different treatment groups randomly. The study team will explain how this works and whether you will know which treatment strategy you are receiving as part of the trial design.