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Study on Ivabradine for Preventing Heart Injury in Patients with Atherosclerosis Undergoing Noncardiac Surgery

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What is this study about?

This clinical trial is focused on studying the effects of the medication Ivabradine on preventing Myocardial Injury after Noncardiac Surgery (MINS). MINS refers to heart damage that can occur after surgeries that do not involve the heart. The trial aims to understand how taking Ivabradine before and after surgery might help reduce the risk of this type of heart injury in patients who have, or are at risk of, atherosclerotic disease, which is a condition where the arteries become narrowed and hardened due to a buildup of plaque.

Participants in the study will be randomly assigned to receive either Ivabradine or a placebo, which is a substance with no active medication. The study will monitor the participants for any signs of heart injury, such as a heart attack or elevated levels of a heart-related protein called cardiac troponin, within 30 days after their surgery. The trial will also look at other outcomes, such as the occurrence of stroke, heart-related death, and overall health and recovery after surgery.

The study will take place over a period of time, with participants being observed for any changes in their health related to the surgery and the medication. The goal is to determine if Ivabradine can effectively prevent heart injury in patients undergoing non-heart-related surgeries, potentially improving their recovery and overall health outcomes.

1 Joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. Written informed consent is required to participate.

Eligibility criteria include being 45 years or older, undergoing noncardiac surgery, and having a history or risk of atherosclerotic disease.

2 Pre-surgery assessment

Before surgery, a detailed medical assessment will be conducted to confirm eligibility and gather baseline health data.

This assessment may include reviewing medical history, current medications, and conducting necessary tests.

3 Medication administration

Participants will receive either ivabradine or a placebo. Ivabradine is administered as a 5 mg film-coated tablet taken orally.

The medication is given perioperatively, meaning it is administered around the time of surgery, to assess its effect on preventing myocardial injury.

4 Surgery and immediate postoperative period

Participants will undergo their scheduled noncardiac surgery. The study will monitor heart health closely during and immediately after the procedure.

The primary focus is on detecting any myocardial injury, which includes heart attacks or elevated cardiac troponin levels indicating heart stress.

5 Post-surgery monitoring

For 30 days following surgery, participants will be monitored for any signs of myocardial injury or other heart-related events.

Secondary outcomes such as vascular death, non-fatal strokes, and quality of life will also be assessed during this period.

6 Follow-up and data collection

Participants will have follow-up visits to collect data on their health status and any adverse effects experienced.

The study aims to gather comprehensive data to evaluate the effectiveness and safety of ivabradine in preventing myocardial injury.

Who Can Join the Study?

  • Must be having surgery that is not related to the heart.
  • Must be 45 years of age or older.
  • Expected to stay in the hospital overnight after surgery.
  • Must provide written consent to participate in the study.
  • Must meet at least one of the following conditions:
    • Have a current or past history of coronary artery disease, which includes:
      • History of angina (chest pain due to reduced blood flow to the heart).
      • History of acute coronary syndrome (a range of conditions associated with sudden, reduced blood flow to the heart).
      • History of abnormal heart wall movement or a fixed defect in heart imaging tests.
      • History of a positive heart stress test showing cardiac ischaemia (reduced blood flow to the heart).
      • Evidence of significant narrowing (50% or more) in any coronary artery from imaging tests.
      • ECG showing specific abnormal patterns in at least two connected leads.
      • Previous procedures to restore blood flow to the heart, like PCI (a procedure to open blocked heart arteries) or CABG (surgery to improve blood flow to the heart).
    • Have peripheral arterial disease, which includes:
      • Intermittent claudication (pain in the legs due to poor blood flow).
      • Previous vascular surgery or procedures to open blocked arteries.
      • Low blood pressure ratio in the legs at rest.
      • Imaging tests showing significant narrowing (more than 70%) in non-heart arteries.
    • Have a history of stroke, which includes:
      • Doctor’s diagnosis of a stroke.
      • Imaging tests showing evidence of a past stroke.
    • Undergoing major vascular surgery, excluding certain procedures like vein stripping or specific aneurysm repairs.
    • Meet any three of the following risk criteria:
      • Undergoing major surgery in specific areas like the abdomen, chest, or major bones.
      • History of congestive heart failure (a condition where the heart doesn’t pump blood as well as it should).
      • History of a transient ischaemic attack (a temporary period of symptoms similar to those of a stroke).
      • Diagnosis of diabetes and currently taking medication for it.
      • Age 70 years or older.
      • History of hypertension (high blood pressure).
      • High levels of serum creatinine (a waste product in the blood) before joining the study.
      • History of smoking within two years of surgery.
      • Undergoing emergency or urgent surgery, which is scheduled to occur within 48 hours of arriving at the hospital.

Who Cannot Join the Study?

  • Patients who have a known allergy or sensitivity to the study medication, ivabradine.
  • Patients who are currently taking medications that may interact negatively with ivabradine.
  • Patients with severe liver problems, as this can affect how the body processes the medication.
  • Patients with certain heart conditions, such as a very slow heart rate or specific types of irregular heartbeats.
  • Patients who are pregnant or breastfeeding, as the effects of the medication on the baby are not known.
  • Patients who have had a recent heart attack or heart surgery, as this may complicate the study results.
  • Patients with uncontrolled high blood pressure, as this can increase the risk of complications.
  • Patients who are participating in another clinical trial, to avoid interference with study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach Katowice Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Lodz Poland
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Cracow Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Pomeranian Medical University Szczecin Poland

Other Sites

Site Name City Country Status
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnow Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
13.06.2022

Trial locations

Investigated drugs:

Ivabradine is a medication used in this trial to help prevent heart injury in patients undergoing non-cardiac surgery. It works by slowing down the heart rate, which can reduce the heart’s workload and oxygen demand. This can be particularly beneficial for patients with or at risk of heart disease, as it may help prevent complications such as heart attacks or other heart-related injuries during or after surgery.

Myocardial Injury after Noncardiac Surgery – This condition occurs when the heart muscle is damaged during or shortly after a noncardiac surgical procedure. It is characterized by an increase in cardiac troponin levels, which are proteins released when the heart muscle is injured. The injury can result from reduced blood flow to the heart, often due to stress or strain on the heart during surgery. Patients may experience symptoms similar to a heart attack, such as chest pain or shortness of breath, although some may not have noticeable symptoms. The condition is identified by monitoring cardiac biomarkers and assessing for signs of heart muscle damage. It is important to recognize and manage this condition to prevent further complications.

Trial ID:
2024-515226-81-00
Protocol code:
PREVENT-MINS
NCT ID:
NCT05279651
Trial Phase:
Therapeutic confirmatory (Phase III)

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