The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology (IMPACT-CTO-2)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Coronary Artery

Detailed Description

Following successful chronic total occlusion (CTO) percutaneous coronary intervention (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.

Quality of life 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United Kingdom
  • Essex
    • Basildon, Essex, United Kingdom, S16 5NL
      • The Essex Cardiothoracic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• < 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in coronary anatomy	To identify intracoronary anatomical features between baseline and follow up.	3 months
Change in exercise work load	Change in exercise work measured in METS (metabolic equivalents).	3 months
Change in quality of life	change in quality measured by the validated Seattle angina seven question questionnaire from baseline to follow up. This is a scale based on 7 questions giving scores of 0-100 on physical limitation, angina, and quality of life, with the average of these scores giving a mean value also ranging from 0-100 of the overall summary score.	3 months
Change in coronary pressure measurements	change in fractional flow reserve (FFR) at baseline and follow up	3 months

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Collaborators: Brighton and Sussex University Hospitals NHS Trust
• Investigators: Principal Investigator: John Davies, MBBS, PhD, Basildon and Thurrock University Hospitals

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2015
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: coronary physiology; absolute flow; CTO - chronic total occlusion; OCT - optical coherence tomography
• Other Study ID Numbers: 240138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No