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Clinical Trials/NCT02570087
NCT02570087
Completed
Not Applicable

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

Hospital Clinic of Barcelona0 sites39 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Total Occlusion Vessel
Sponsor
Hospital Clinic of Barcelona
Enrollment
39
Primary Endpoint
Left ventricular ejection fraction (%)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Montserrat Cardona

Consultant

Hospital Clinic of Barcelona

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

Outcomes

Primary Outcomes

Left ventricular ejection fraction (%)

Time Frame: 6 months

Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI

Secondary Outcomes

  • NYHA functional class (I-V)(6 months)
  • Myocardial ischemia(6 months)
  • Brain Natriuretic Peptide (pg/ml)(6 months)
  • Incidence of in-hospital CTO PCI major adverse events(6 months)

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