Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion

NCT03522038 | Unknown DMC

• 1 other identifier: ZS-CV-201801
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Occlusion; Angioplasty, Balloon, Coronary

Keywords

coronary chronic total occlusion; functional evaluation

Outcome Measures

Primary Outcomes (4)

• Change from Baseline FFR at 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.

  At baseline and 6 months after CTO PCI

• Change from Baseline FFR at 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.

  At baseline and 6 months after CTO PCI

• Change from Baseline Myocardial perfusion at 6 months after CTO PCI

  The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.

  At baseline and 6 months after CTO PCI

• Change from Baseline Myocardial Viability at 6 months after CTO PCI

  The myocardial viability before and after CTO PCI was evaluated by PET-MRI.

  At baseline and 6 months after CTO PCI

Secondary Outcomes (2)

• MACE

  6 months after CTO PCI

• In-stent restenosis

  6 months after CTO PCI

Interventions

percutaneous coronary intervention PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

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.

MeSH Terms

Conditions

Coronary Occlusion

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Junbo Ge, MD

CONTACT

86-21-64041990; jbge@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 11, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: May 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share