Clinical trial NCT02570087: Benefits of CTO-PCI in Selected Cases With HFrEF (CTOHFrEF)
Official title: Benefits of Chronic Total Coronary Occlusion Percutaneous Intervention in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion Vessel
Keywords: Coronary ChronicTotal Occlusion
Coronary Angioplasty
Reduced Ejection Fraction
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction (%)
timeFrame: 6 months
Secondary outcomes:
measure: NYHA functional class (I-V)
timeFrame: 6 months
measure: Myocardial ischemia
timeFrame: 6 months
measure: Brain Natriuretic Peptide (pg/ml)
timeFrame: 6 months
measure: Incidence of in-hospital CTO PCI major adverse events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.