Benefits of CTO-PCI in Selected Cases With HFrEF (CTOHFrEF)

Study Overview
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Brief Summary
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The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.

Detailed Description
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Observational studies have shown that chronic total coronary occlusion percutaneous intervention (CTO-PCI) improves angina, left ventricular ejection fraction (LVEF), and survival. None of these studies aimed to assess the benefits in populations with heart failure with reduced ejection fraction (HFrEF). The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF. Using cardiac magnetic resonance (CMR), the investigators studied 29 patients with HFrEF and evidence of viability and/or ischemia in the territory supplied by an occluded vessel who were successfully treated with CTO-PCI. Non-CTO PCI was also performed in patients with multi-vessel disease, . Imaging parameters, clinical status, and brain natriuretic peptide (BNP) levels were evaluated before and six months after CTO-PCI.

Official Title
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Benefits of Chronic Total Coronary Occlusion Percutaneous Intervention in Patients With Chronic Heart Failure and Reduced Ejection Fraction.

Conditions
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Chronic Total Occlusion Vessel

Intervention / Treatment
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* Procedure: chronic total coronary occlusion percutaneous intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least one chronic total coronary occlusion LVEF ≤40% by CMR Evidence of myocardial viability and/or ischemia in at least two contiguous segments subtended by the occluded vessel. Exclusion Criteria: Women of childbearing age or pregnant Claustrophobia Admission to hospital within the previous 90 days due to decompensated heart failure, myocardial infarction or unstable angina. Severe valvulopathy Pacemaker or implantable cardioverter defibrillator Indication for coronary artery bypass surgery Heart transplantation waiting list Follow-up not feasible Life expectancy shorter than 12 months. Iodine contrast or gadolinium allergy Aspirin or clopidogrel allergy Asthma NYHA IV class Liver cirrosis Noncompliance with medical treatment Chronic kidney disease with serum creatinine levels ≥ 2.5 mg/dl or glomerular filtration rate ≤30 ml/min/1.73m2 Evidence of active bleeding High risk of bleeding CTO distal vessel not visible through collateral circulation CTO distal vessel diameter <2mm Absence of acceptable vascular access

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Successful CTO PCI<br>Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI) | Procedure: chronic total coronary occlusion percutaneous intervention<br>* Percutaneous intervention of chronic total coronary occlusion with stent implantation<br>|
| No Intervention: Unsuccessful CTO PCI<br>Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (%) | Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA functional class (I-V) | Evaluate changes in NYHA functional class 6 months after CTO PCI | 6 months | 
| Myocardial ischemia | Evaluate changes in number of segments with induced ischemia by cardiac magnetic resonance imaging 6 months after CTO PCI | 6 months | 
| Brain Natriuretic Peptide (pg/ml) | Evaluate changes in brain natriuretic peptide 6 months after CTO PCI | 6 months | 
| Incidence of in-hospital CTO PCI major adverse events | Safety evaluation of CTO PCI in patients with HFrEF (periprocedural mortality, periprocedural STEMI or need for urgent myocardial revascularization surgery) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary ChronicTotal Occlusion, Coronary Angioplasty, Reduced Ejection Fraction