The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology

NCT03830853 | Completed

• 1 other identifier: 240138
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Following successful CTO PCI, a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity. This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up. QoL measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life. Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

CTO - chronic total occlusion; OCT - optical coherence tomography; coronary physiology; absolute flow

Outcome Measures

Primary Outcomes (2)

• Change in coronary flow

  change in coronary flow at baseline and follow up

  3 months

• Change in coronary resistance

  change in coronary absolute resistance at baseline and follow up

  3 months

Secondary Outcomes (4)

• Change in coronary anatomy

  3 months

• Change in exercise work load

  3 months

• Change in quality of life

  3 months

• Change in coronary pressure measurements

  3 months

Study Arms (1)

Successful CTO PCI achieved

Patients will have successful CTO PCI (chronic total occlusion percutaneous coronary intervention) followed by physiological and intracoronary imaging. These measurements will be repeated at a 3 month follow up angiogram procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been selected for elective percutaneous coronary angioplasty (PCI) of their chronic total occlusion (CTO) as part of routine standard of care will be approached for the study.

You may qualify if:

• years of age
• Presence of a coronary chronic total occlusion (CTO) scheduled for elective percutaneous coronary angioplasty (PCI)
• Evidence of viability in the CTO Territory

You may not qualify if:

• \< 18 year of age
• Unable to give informed consent
• Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
• Unable to receive antiplatelets or periprocedural anticoagulation
• Contraindications to adenosine
• Any study lesion characteristic resulting in the expected inability to deliver FD-OCT catheter at the distal vessel post CTO PCI (e.g. moderate or severe vessel calcification or tortuosity)
• Pregnancy, planning pregnancy during study period, or breastfeeding

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Brighton and Sussex University Hospitals NHS Trust: collaborator

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, S16 5NL, United Kingdom

Location

Study Officials

• John Davies, MBBS, PhD

  Basildon and Thurrock University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 5, 2019
• Study Start: January 23, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)