Active — Not RecruitingNot Applicable

The Nordic Baltic Chronic Total Occlusion (CTO) Arrhythmia Study

Denmark200 participantsStarted 2020-11-01

Plain-language summary

In patients with a chronic total coronary occlusion (CTO ), clinically significant arrhythmia seems to be an important and a poorly investigated problem. The arrhythmia prevalence in an all-comer CTO-population is unknown, but in ICD-populations with ischemic heart disease, a CTO may be found in half of patients with life-threatening arrhythmia.The purpose of the CTO-ARRHYTHMIA study, is to investigate the incidence of clinically significant arrhythmias in CTO patients using an implantable loop recorder. Further, the investigators intend to identify predictors for arrhythmias as well as the impact on arrhythmia of optimized pharmacological treatment and revascularization in CTO patients.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥1 CTO lesion amenable to PCI. * Stable or stabilized coronary artery disease. * Angiographic/echocardiographic signs of reversible perfusion. * CTO lesion in a coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm). Exclusion Criteria: * Expected survival \<1 year. * Patients with an indication of ICD due to EF \< 35 or previous ventricular tachycardia. * Patients with a cardiac device i.e. ICD, pacemaker or cardiac resynchronizing treatment device. * Renal failure on dialysis. * Lesions treated with PCI within one month. * Indication for coronary artery bypass grafting (CABG). I.e. Two-or three vessel disease or left main disease and a syntax score \>22. * Significant valvular heart disease. * Declined informed consent. * Regarding CMRI: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants.

What they're measuring

Rate of clinically significant arrhythmias

Timeframe: 1 year

Trial details

NCT IDNCT04542460

SponsorLeif Thuesen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01