Ongoing Clinical Trials for Myocardial Ischaemia
This article provides information about 6 ongoing clinical trials studying new treatments for myocardial ischaemia, a condition where the heart muscle does not receive enough blood and oxygen. These trials are exploring various medications and treatment approaches, including anti-inflammatory drugs, psychotherapy-assisted treatments, heart rate-lowering medications, and novel imaging techniques to better understand and treat this serious heart condition. Trials are being conducted across several European countries including Denmark, Czechia, Sweden, Poland, France, Romania, Hungary, and the Netherlands.
Clinical trial locations
- Czechia
- Denmark
- France
- Hungary
- Netherlands
- Poland
- Romania
- Sweden
Study on Dexamethasone and Olanzapine for Patients Undergoing Heart Surgery
This trial is taking place in Denmark and focuses on patients undergoing heart surgery for coronary artery bypass grafting or heart valve replacement. The study aims to explore whether two medications, dexamethasone and olanzapine, can improve recovery outcomes after heart surgery.
Who can participate: The trial is open to adults over 18 years old who are scheduled for coronary artery bypass grafting or aortic valve replacement surgery. Participants may also be having additional valve surgeries at the same time.
Who cannot participate: Patients not undergoing these specific types of heart surgery, those who are not adults, or individuals who belong to vulnerable populations requiring special protection or care cannot join the study.
Main focus: The study examines whether dexamethasone, an anti-inflammatory steroid, and olanzapine, typically used for mental health conditions, can reduce complications, shorten hospital stays, and improve overall recovery. Participants will be monitored for up to 90 days after surgery to track recovery progress, including survival rates, complications such as stroke or kidney injury, and overall quality of life.
Investigational drugs: Dexamethasone is given through injection into a vein during surgery to help reduce inflammation. Olanzapine is given as a 20 mg tablet that dissolves in the mouth before surgery. The trial also tests different methods of managing blood flow and breathing during surgery to see if these can further support recovery.
Study on Psilocybin and Midazolam for Reducing Atherosclerosis in Patients with Coronary Artery Disease
This trial in Czechia investigates whether psilocybin-assisted psychotherapy or midazolam-assisted psychotherapy can help reduce atherosclerotic plaques in the heart’s arteries. These plaques are fatty deposits that narrow the arteries and reduce blood flow to the heart.
Who can participate: Men and women aged 18 to 75 years with stable coronary artery disease who have had a heart attack at least 6 weeks before joining the study can participate. They must have a coronary artery narrowing that is at least 2.5 mm wide but not more than 50% blocked, and the artery should not have had previous medical procedures. Participants must be able to understand the study information and use prescribed contraceptive methods during the trial.
Who cannot participate: Individuals outside the specified age range, those without ischemic heart disease, patients unable to undergo required medical examinations or follow the treatment plan, those with interfering medical conditions, and pregnant or breastfeeding women cannot participate. Individuals unable to give informed consent are also excluded.
Main focus: The study explores whether psychotherapy combined with either psilocybin or midazolam can lead to a reduction in plaque volume in the heart’s arteries over 12 months. Researchers use Optical Coherence Tomography imaging to monitor changes in plaque volume and composition, hoping to improve heart health and reduce the risk of heart-related complications.
Investigational drugs: Psilocybin is a psychedelic compound taken orally in capsule form as part of psychotherapy sessions. Midazolam, also taken orally in capsule form, is used as a control treatment to compare against psilocybin’s effects.
Study on the Effects of Different Doses of Adenosine for Patients with Chronic Coronary Syndrome, with and without Heart Failure
This Swedish trial examines how different doses of adenosine affect heart blood flow in patients with Chronic Coronary Syndrome, a condition where the heart’s blood supply is gradually reduced due to narrowed arteries.
Who can participate: The study includes healthy individuals and patients with suspected or known Chronic Coronary Syndrome, with or without heart failure. Participants must have given written consent and must match specific criteria for sex and age, with 6 females and 6 males from each age group between 40 and over 80 years. Participants must not have consumed caffeine for at least 24 hours before the examination.
Who cannot participate: Patients with known allergy to adenosine, severe asthma or serious lung diseases, very low blood pressure, certain heart rhythm problems such as second or third-degree heart block, pregnant or breastfeeding women, those who have had a heart attack or stroke in the last three months, patients with severe liver or kidney disease, and anyone currently participating in another clinical trial are excluded.
Main focus: The study compares a standard dose of adenosine with a higher dose to understand how each affects the heart’s blood flow. Using Cardiac Magnetic Resonance imaging, researchers measure changes in blood flow to determine the most effective dose for patients with this heart condition.
Investigational drugs: Adenosine is administered through an intravenous infusion. It works by widening blood vessels to increase blood flow to the heart muscle, helping doctors assess heart function during stress tests.
Study on [68Ga]NODAGA-E[c(RGDyK)]2 for Imaging Blood Vessel Growth in Patients with Chronic Ischemic Heart Disease
This Danish trial uses a special imaging agent to visualize blood vessel growth in the heart of patients with chronic ischemic heart disease, a condition where the heart doesn’t receive enough blood due to narrowed or blocked vessels.
Who can participate: Participants must be older than 50 years, admitted to the Heart Center at Rigshospitalet, have a chronic occlusion of coronary arteries, and be referred for either percutaneous coronary intervention or coronary artery bypass grafting. Both men and women are eligible.
Who cannot participate: Patients without chronic ischemic heart disease, those outside the specified age range, and individuals who are part of vulnerable populations cannot participate.
Main focus: The study examines how blood vessel growth in the heart changes before and after procedures to restore blood flow. Participants undergo imaging sessions before the procedure, immediately after, and at follow-up appointments to monitor the heart’s healing and adaptation after treatment.
Investigational drugs: [68Ga]NODAGA-E[c(RGDyK)]2 is a radiopharmaceutical imaging agent administered through intravenous injection. It helps visualize the formation of new blood vessels in the heart during PET scans, providing detailed images that assist doctors in evaluating heart health.
Study on Ivabradine for Preventing Heart Injury in Patients with Atherosclerosis Undergoing Noncardiac Surgery
This Polish trial investigates whether ivabradine can prevent heart injury in patients with or at risk of atherosclerotic disease who are undergoing surgery that does not involve the heart.
Who can participate: Adults aged 45 years or older undergoing noncardiac surgery with an expected overnight hospital stay can participate. They must have written consent and meet at least one condition: current or past coronary artery disease, peripheral arterial disease, history of stroke, undergoing major vascular surgery, or meeting three specific risk criteria including age 70 or older, diabetes requiring medication, or history of high blood pressure.
Who cannot participate: Patients with known allergy to ivabradine, those taking medications that interact negatively with it, individuals with severe liver problems, certain heart conditions such as very slow heart rate or specific irregular heartbeats, pregnant or breastfeeding women, those who have had recent heart attack or heart surgery, patients with uncontrolled high blood pressure, and those participating in another clinical trial are excluded.
Main focus: The study aims to determine if taking ivabradine before and after surgery can reduce the risk of heart injury. Participants are randomly assigned to receive either ivabradine or a placebo and are monitored for 30 days after surgery for signs of heart injury, such as heart attacks or elevated cardiac troponin levels, as well as stroke and overall health outcomes.
Investigational drugs: Ivabradine is a heart rate-lowering medication given as a 5 mg tablet taken orally around the time of surgery. It works by slowing the heart rate, reducing the heart’s workload and oxygen demand, which may help prevent complications during and after surgery.
Study on the Effects of Zalunfiban for Patients with ST-Elevation Myocardial Infarction (Heart Attack)
This trial is conducted across five European countries—France, Romania, Hungary, the Netherlands, and Czechia—and focuses on patients experiencing ST-elevation myocardial infarction, a serious type of heart attack where part of the heart muscle is suddenly blocked from receiving blood.
Who can participate: Males aged 18 years or older and females who are post-menopausal or surgically sterile aged 50 years or older can participate. Participants must weigh between 52 and 130 kg and have documented presumed STEMI with persistent chest pain lasting more than 10 minutes and specific changes in heart electrical activity. The total duration from symptoms to diagnostic test should be a maximum of 4 hours. Participants must be planned for transport to a participating clinical site and provide verbal or written informed consent.
Who cannot participate: The trial excludes patients who do not meet the specific criteria for STEMI presentation, including the required chest pain duration and electrical activity changes, or whose symptom duration exceeds the specified timeframe.
Main focus: The study compares a single injection of zalunfiban with a placebo to assess safety and effectiveness. Participants receive the injection before reaching the hospital, and researchers monitor them for major health events such as death, stroke, or another heart attack, as well as any bleeding incidents, for 30 days after treatment.
Investigational drugs: Zalunfiban is an antiplatelet medication given as a single injection under the skin. It works by blocking certain proteins in the blood that cause blood clots, helping to keep blood flowing smoothly to the heart during a heart attack.
Summary
These 6 ongoing clinical trials represent diverse approaches to understanding and treating myocardial ischaemia and related heart conditions. The trials span several European countries, with notable presence in Denmark, Czechia, and a multi-country trial across France, Romania, Hungary, and the Netherlands.
The research encompasses various treatment strategies, from traditional anti-inflammatory medications like dexamethasone to innovative approaches such as psychedelic-assisted psychotherapy with psilocybin. Several trials focus on optimizing existing medications like adenosine and ivabradine, while others explore novel imaging techniques to better visualize heart healing processes. The zalunfiban trial addresses acute emergency treatment for heart attacks, while other studies concentrate on chronic conditions and surgical recovery.
The trials include patients at different stages of heart disease, from those undergoing planned surgery to individuals experiencing acute heart attacks. This range of research reflects the medical community’s comprehensive effort to improve outcomes for patients with heart conditions through multiple therapeutic approaches and better diagnostic tools.
