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

H

Hospital Clinic of Barcelona

Status

Completed

Conditions

Chronic Total Occlusion Vessel

Treatments

Procedure: chronic total coronary occlusion percutaneous intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02570087
CTOHFrEF

Details and patient eligibility

About

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

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

39 participants in 2 patient groups

Successful CTO PCI
Active Comparator group
Description:
Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI)
Treatment:
Procedure: chronic total coronary occlusion percutaneous intervention
Unsuccessful CTO PCI
No Intervention group
Description:
Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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