Investigating arrhythmias in patients with chronic total coronary occlusion
Chronic Total Coronary Occlusion; Arrhythmia in Patients With Adjunction of PCI to Optimal Medical Treatment Versus Optimal Medical Treatment and in Patients With Failed PCI.
This study is testing how often serious heart rhythm problems happen in people with blocked coronary arteries and whether better treatments can help improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg, Region Nordjylland) |
| Trial ID | NCT04542460 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the incidence of clinically significant arrhythmias in patients suffering from chronic total coronary occlusion (CTO) using an implantable loop recorder. It will also identify predictors for these arrhythmias and assess the impact of optimized pharmacological treatment and revascularization through percutaneous coronary intervention (PCI) in CTO patients. The study focuses on a population where CTO is prevalent, particularly among those with ischemic heart disease. By understanding the relationship between CTO and arrhythmias, the study seeks to improve patient outcomes through targeted interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with at least one CTO lesion that can be treated with PCI and who have stable coronary artery disease.
Not a fit: Patients who are expected to survive less than one year or those with significant valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for patients with chronic total coronary occlusion, potentially reducing the incidence of life-threatening arrhythmias.
How similar studies have performed: While the specific approach of this study may be novel, there is existing literature indicating that understanding arrhythmias in ischemic heart disease populations can lead to improved treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aalborg, Region Nordjylland
- Aalborg university hospital — Aalborg, Region Nordjylland, Denmark (Recruiting)
Study contacts
- Study coordinator: Leif Thuesen, DMSc
- Email: leif.thuesen@rn.dk
- Phone: +4597664465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.