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Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522038
Recruitment Status : Unknown
Verified April 2018 by Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
The aim of this study is to investigate the role of functional evaluation for predicting clinical outcome in patients with coronary chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI), and to evaluate the clinical evidence for the using of fractional flow reserve (FFR), coronary flow reserve (CFR), index of myocardial resistance (IMR) and dynamic single photon emission computed tomography (D-SPECT) in these patients.

Condition or disease Intervention/treatment
Coronary Occlusion Angioplasty, Balloon, Coronary Procedure: percutaneous coronary intervention

Detailed Description:

PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown.

The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty


Intervention Details:
  • Procedure: percutaneous coronary intervention
    PCI was performed using standard techniques. Antiplatelet and antithrombotic agents were prescribed according to current PCI guidelines. A procedure was considered successful when achieving TIMI flow grade 3 with <30% angiographic residual stenosis in the CTO vessel. All patients received drug-eluting stents and were discharged on dual antiplatelet therapy with duration of at least on year.


Primary Outcome Measures :
  1. Change from Baseline FFR at 6 months after CTO PCI [ Time Frame: At baseline and 6 months after CTO PCI ]
    FFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel. FFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route. The FFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.

  2. Change from Baseline FFR at 6 months after CTO PCI [ Time Frame: At baseline and 6 months after CTO PCI ]
    CFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel. CFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route. The CFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.

  3. Change from Baseline Myocardial perfusion at 6 months after CTO PCI [ Time Frame: At baseline and 6 months after CTO PCI ]
    The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.

  4. Change from Baseline Myocardial Viability at 6 months after CTO PCI [ Time Frame: At baseline and 6 months after CTO PCI ]
    The myocardial viability before and after CTO PCI was evaluated by PET-MRI.


Secondary Outcome Measures :
  1. MACE [ Time Frame: 6 months after CTO PCI ]
    A major adverse cardiac event (MACE) was defined as the occurrence of cardiac death, nonfatal MI, and target lesion revascularization during the follow-up period.

  2. In-stent restenosis [ Time Frame: 6 months after CTO PCI ]
    In-stent restenosis was defined as >50% diameter stenosis by quantitative coronary angiography within a previously stented CTO vessel segment.


Biospecimen Retention:   Samples With DNA
2 samples of EDTA blood (2ml glass) and 1 sample of serum (5ml glass) will be retained in a biobank.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary CTOs were defined as coronary lesions with Thrombolysis in Myocardial Infarction (TIMI) grade 0 flow of at least 3-month duration. Estimation of the occlusion duration was based on first onset of anginal symptoms, prior history of MI in the target vessel territory, or comparison with a prior angiogram.
Criteria

Inclusion Criteria:

  • Age ≥ 18 and ≤80
  • Patients diagnosed with CTO by coronary angiography
  • Patient planned to receive PCI
  • Diameter of CTO vessel > 2.25 mm

Exclusion Criteria:

  • Age >80 or <18
  • Myocardial infarction with 1 months
  • Inability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522038


Contacts
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Contact: Junbo Ge, MD 86-21-64041990 ext 2728 jbge@zs-hospital.sh.cn

Sponsors and Collaborators
Shanghai Zhongshan Hospital
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03522038    
Other Study ID Numbers: ZS-CV-201801
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
coronary chronic total occlusion
functional evaluation
Additional relevant MeSH terms:
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Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases