CompletedNCT02570087CTOHFrEFUpdated Oct 7, 2015

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

An interventional study of chronic total coronary occlusion percutaneous intervention in Chronic Total Occlusion Vessel, sponsored by Hospital Clinic of Barcelona. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-07.

Sponsored by Hospital Clinic of Barcelona · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 39
Allocation: Non-randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Chronic Total Occlusion Vessel

Keywords

Coronary ChronicTotal Occlusion
Coronary Angioplasty
Reduced Ejection Fraction

In context

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 39 participants (actual)

Study arms

Active comparator
Successful CTO PCI
Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI)
Procedure: chronic total coronary occlusion percutaneous intervention
No intervention
Unsuccessful CTO PCI
Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI)

Interventions

Procedurechronic total coronary occlusion percutaneous intervention
Percutaneous intervention of chronic total coronary occlusion with stent implantation

What researchers measure

Primary outcomes

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

Secondary outcomes

NYHA functional class (I-V)
Evaluate changes in NYHA functional class 6 months after CTO PCI
Time frame: 6 months
Myocardial ischemia
Evaluate changes in number of segments with induced ischemia by cardiac magnetic resonance imaging 6 months after CTO PCI
Time frame: 6 months
Brain Natriuretic Peptide (pg/ml)
Evaluate changes in brain natriuretic peptide 6 months after CTO PCI
Time frame: 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)
Time frame: 6 months

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 27814739 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02570087
Lead sponsor: Hospital Clinic of Barcelona
Responsible party: Montserrat Cardona (Consultant, Hospital Clinic of Barcelona) — Principal investigator
First posted: Oct 7, 2015
Start date: Jul 2011
Primary completion: Aug 2014
Completion: Dec 2014
Last update: Oct 7, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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