Benefits of CTO-PCI in Selected Cases With HFrEF (CTOHFrEF)
NCT ID: NCT02570087
Last Updated: 2015-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2011-07-31
2014-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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Successful CTO PCI
Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI)
chronic total coronary occlusion percutaneous intervention
Percutaneous intervention of chronic total coronary occlusion with stent implantation
Unsuccessful CTO PCI
Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI)
No interventions assigned to this group
Interventions
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chronic total coronary occlusion percutaneous intervention
Percutaneous intervention of chronic total coronary occlusion with stent implantation
Eligibility Criteria
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Inclusion Criteria
* LVEF ≤40% by CMR
* Evidence of myocardial viability and/or ischemia in at least two contiguous segments subtended by the occluded vessel.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Montserrat Cardona
Consultant
References
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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.
Other Identifiers
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CTOHFrEF
Identifier Type: -
Identifier Source: org_study_id
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