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OpenTrials
Completed

NCT Number: NCT02570087

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chronic total coronary occlusion percutaneous intervention

Procedure

Percutaneous intervention of chronic total coronary occlusion with stent implantation

Primary outcomes

  1. 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

  1. NYHA functional class (I-V)

    Time frame: 6 months

    Evaluate changes in NYHA functional class 6 months after CTO PCI

  2. Myocardial ischemia

    Time frame: 6 months

    Evaluate changes in number of segments with induced ischemia by cardiac magnetic resonance imaging 6 months after CTO PCI

  3. Brain Natriuretic Peptide (pg/ml)

    Time frame: 6 months

    Evaluate changes in brain natriuretic peptide 6 months after CTO PCI

  4. Incidence of in-hospital CTO PCI major adverse events

    Time frame: 6 months

    Safety evaluation of CTO PCI in patients with HFrEF (periprocedural mortality, periprocedural STEMI or need for urgent myocardial revascularization surgery)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: CTOHFrEF

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 7, 2015
Registry last updated
Oct 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.