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

Not Applicable

Completed

• Conditions: Chronic Total Occlusion Vessel
• Interventions: Procedure: chronic total coronary occlusion percutaneous intervention

• Registration Number: NCT02570087
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Study First Submitted: 2015-09-25
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-05
• Last Update Submitted: 2015-10-05
• Study First Posted: 2015-10-07
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Successful CTO PCI	chronic total coronary occlusion percutaneous intervention	Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI)

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (%)	6 months	Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI

Secondary Outcome Measures

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