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

NCT ID: NCT02570087

Last Updated: 2015-10-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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

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Chronic Total Occlusion Vessel

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Successful CTO PCI

Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI)

Group Type ACTIVE_COMPARATOR

chronic total coronary occlusion percutaneous intervention

Intervention Type PROCEDURE

Percutaneous intervention of chronic total coronary occlusion with stent implantation

Unsuccessful CTO PCI

Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI)

Group Type NO_INTERVENTION

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Montserrat Cardona

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type DERIVED
PMID: 27814739 (View on PubMed)

Other Identifiers

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CTOHFrEF

Identifier Type: -

Identifier Source: org_study_id

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