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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion Vessel
• Intervention / Treatment: Procedure: chronic total coronary occlusion percutaneous intervention

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Cardona M, Martin V, Prat-Gonzalez S, Ortiz JT, Perea RJ, de Caralt TM, Masotti M, Perez-Villa F, Sabate M. Benefits of chronic total coronary occlusion percutaneous intervention in patients with heart failure and reduced ejection fraction: insights from a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2016 Nov 5;18(1):78. doi: 10.1186/s12968-016-0287-5.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 25, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Estimate): October 7, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Coronary Angioplasty; Reduced Ejection Fraction; Coronary ChronicTotal Occlusion
• Other Study ID Numbers: CTOHFrEF