Chronic Total Occlusion VesselCTOHFrEFNCT02570087
Benefits of CTO-PCI in Selected Cases With HFrEF (CTOHFrEF)
A study testing chronic total coronary occlusion percutaneous intervention in people with Chronic Total Occlusion Vessel, run by Hospital Clinic of Barcelona.
Trial summary
The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Total Occlusion Vessel
- What is being tested?
- chronic total coronary occlusion percutaneous intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
Official title: Benefits of Chronic Total Coronary Occlusion Percutaneous Intervention in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.
Read the 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.
- Conditions
- Chronic Total Occlusion Vessel
- Being tested
- chronic total coronary occlusion percutaneous intervention
- Keywords
- Coronary ChronicTotal Occlusion, Coronary Angioplasty, Reduced Ejection Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic total coronary occlusion percutaneous interventionProcedure or surgery
Percutaneous intervention of chronic total coronary occlusion with stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Successful CTO PCI | Active comparator | Successful chronic total coronary occlusion percutaneous intervention (CTO-PCI) Receives: Procedure: chronic total coronary occlusion percutaneous intervention |
| Unsuccessful CTO PCI | No intervention | Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (%)
Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI
Measured: 6 months
Secondary outcomes (4)
NYHA functional class (I-V)
Evaluate changes in NYHA functional class 6 months after CTO PCI
Measured: 6 months
Myocardial ischemia
Evaluate changes in number of segments with induced ischemia by cardiac magnetic resonance imaging 6 months after CTO PCI
Measured: 6 months
Brain Natriuretic Peptide (pg/ml)
Evaluate changes in brain natriuretic peptide 6 months after CTO PCI
Measured: 6 months
Incidence of in-hospital CTO PCI major adverse events
Safety evaluation of CTO PCI in patients with HFrEF (periprocedural mortality, periprocedural STEMI or need for urgent myocardial revascularization surgery)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJul 2011
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion VesselStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Cardona, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570087
- Sponsor's protocol ID
- CTOHFrEF
- Acronym
- CTOHFrEF
- Status last verified
- Oct 2015
- First submitted
- 25 Sep 2015
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27814739
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Chronic Total Coronary Occlusion Percutaneous Intervention in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
- ClinicalTrials.gov ID
- NCT02570087
- Acronym / sponsor ID
- CTOHFrEF / CTOHFrEF
- Conditions
- Chronic Total Occlusion Vessel
- Keywords
- Coronary ChronicTotal Occlusion, Coronary Angioplasty, Reduced Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful CTO PCI | Active comparator | Procedure: chronic total coronary occlusion percutaneous interventionSuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI) |
| Unsuccessful CTO PCI | No intervention | –Unsuccessful chronic total coronary occlusion percutaneous intervention (CTO-PCI) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronic total coronary occlusion percutaneous interventionPercutaneous intervention of chronic total coronary occlusion with stent implantation | Procedure or surgery | Successful CTO PCI |
Primary outcome
Left ventricular ejection fraction (%)
Time frame: 6 months
Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI
4 secondary outcomes
NYHA functional class (I-V)
Time frame: 6 months
Myocardial ischemia
Time frame: 6 months
Brain Natriuretic Peptide (pg/ml)
Time frame: 6 months
Incidence of in-hospital CTO PCI major adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
- Derived from this study: PubMed 27814739Cardona 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing chronic total coronary occlusion percutaneous intervention in people with Chronic Total Occlusion Vessel, run by Hospital Clinic of Barcelona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (%) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2015.