Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who are able to provide written consent to participate
• People who meet at least one "major" or two "minor" bleeding risk factors, as defined by an international research standard called the Academic Research Consortium (ARC)

Major bleeding risk factors include:

• Currently taking long-term blood-thinning medication (anticoagulants)
• Having severely reduced kidney function (eGFR below 30 ml/min)
• Having a low red blood cell level (haemoglobin below 110 g/l)
• Having had a spontaneous bleeding episode in the past 6 months that required a hospital stay and blood transfusion
• Having a significantly low platelet count (below 100 x 10⁹/L)
• Having a long-term condition that causes abnormal bleeding
• Having liver cirrhosis with high blood pressure in the liver's blood vessels
• Having been diagnosed with an active cancer in the past 12 months
• Having previously had a bleed inside the brain that occurred on its own (at any time)
• Having had a brain bleed caused by injury within the past 12 months
• Having a known abnormal connection between blood vessels in the brain
• Having had a moderate to severe stroke within the past 6 months
• Needing major surgery that cannot be delayed while on dual blood-thinning medications
• Having had major surgery or a serious injury within 30 days before the heart procedure

Minor bleeding risk factors include:

• Being over 75 years of age
• Having moderately reduced kidney function (eGFR 30–59 ml/min)
• Having a mildly low haemoglobin level (110–129 g/l for men or 110–119 g/l for women)
• Having had a spontaneous bleeding episode requiring hospitalisation or transfusion within the past 12 months that does not meet the major criterion above
• Taking anti-inflammatory medications (such as NSAIDs) or steroids long-term
• Having had any stroke at any time that does not meet the major criterion above

Heart condition criteria — people must have one of the following:

• Stable chest pain or breathlessness, with a narrowed coronary artery confirmed to be causing reduced blood flow to the heart muscle, detected during heart imaging
• A recent heart event (unstable angina or a type of heart attack called NSTEMI), with specific changes seen on a heart tracing (ECG) and/or elevated heart enzyme levels in blood tests

Artery/procedure criteria — people must also have at least one of the following:

• One or more new blockages in the heart's own arteries or in bypass grafts
• A blood vessel of a size that falls within the treatable range for this trial (2.0–5.0 mm in diameter)
• A blockage length of 40 mm or less
• A blockage that is suitable for the type of heart procedure used in this trial (PCI)

Who may not be able to join:

• People who are unable to provide written consent
• People who are having a particular type of severe heart attack called a STEMI
• People whose affected blood vessel is smaller than 2.0 mm or larger than 5.0 mm in diameter
• People who have a complex type of artery blockage at a branching point that requires stenting of one of the branches after an initial balloon procedure
• People who experience a tear in the artery wall or significant recoil affecting blood flow after the initial balloon procedure
• People whose blockage is inside a previously placed stent (in-stent restenosis)
• People who have a completely blocked artery that has been blocked for a long time (chronic total occlusion)
• People whose life expectancy is less than 12 months
• People who arrive at the procedure in a state of severe heart-related shock
• People where there is uncertainty about recovery of brain function, for example after resuscitation
• People for whom the heart care team has determined that open-heart bypass surgery is needed

Important: Always verify eligibility with the trial site directly before applying.