Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS

Launched by CENTRO PER LA LOTTA CONTRO L'INFARTO - FONDAZIONE ONLUS · Aug 24, 2021

Keywords

ClinConnect Summary

The INTERCLIMA trial is studying the best way to treat certain heart conditions in patients experiencing acute coronary syndrome (ACS), which is a type of serious heart problem. Specifically, it looks at two different approaches: one that uses a special imaging technique called optical coherence tomography (OCT) to identify vulnerable areas in the coronary arteries, and another that relies on physiological measurements to assess blood flow. This study will involve about 1,400 patients from around 40 different hospitals worldwide, aiming to find out which method is more effective for treating non-culprit lesions—areas in the heart that aren't currently causing problems but could still lead to future issues.

To be eligible for this trial, participants need to be at least 18 years old and diagnosed with ACS. They should have a specific type of blockage in a major coronary artery that isn’t too severe (between 40-70% blockage) and have no other significant blockages in the same vessel. If someone decides to participate, they can expect to undergo a procedure where their heart condition will be assessed and treated based on one of the two approaches being studied. It's important to note that certain conditions, like serious kidney problems or advanced heart failure, may prevent someone from joining the trial. Overall, the goal of this study is to improve treatment strategies for patients with ACS and help prevent future heart issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age of at least 18 years.
• • Diagnosis of acute coronary syndrome.
• • Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\>70%) in the same vessel.
• • Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.
• • Life expectancy \>3 years.
• Exclusion criteria:
• • Female with childbearing potential or lactating.
• • Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl).
• • Advanced heart failure (NYHA III-IV)
• • Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.
• • Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.
• • Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).
• • Lesions located in the left main coronary artery
• • Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.
• • Prior myocardial infarction or coronary artery bypass graft \[CABG\] or PCI revascularization in the target coronary vessel.
• • Coronary anatomy unsuitable for PCI.
• • Comorbidities that might interfere with completion of the study procedures.
• • Planned major surgery necessitating interruption of dual antiplatelet.
• • Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.