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

Sponsor

Mid and South Essex NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03830853

Collaborator

Brighton and Sussex University Hospitals NHS Trust (Other)

Enrollment

Location

35.3

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

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 Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 23, 2015

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Change in coronary flow [3 months]
change in coronary flow at baseline and follow up
Change in coronary resistance [3 months]
change in coronary absolute resistance at baseline and follow up

Secondary Outcome Measures

Change in coronary anatomy [3 months]
To identify intracoronary anatomical features between baseline and follow up.
Change in exercise work load [3 months]
Change in exercise work measured in METS (metabolic equivalents).
Change in quality of life [3 months]
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.
Change in coronary pressure measurements [3 months]
change in fractional flow reserve (FFR) at baseline and follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Essex Cardiothoracic Centre	Basildon	Essex	United Kingdom	S16 5NL

Sponsors and Collaborators

Mid and South Essex NHS Foundation Trust
Brighton and Sussex University Hospitals NHS Trust

Investigators

Principal Investigator: John Davies, MBBS, PhD, Basildon and Thurrock University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mid and South Essex NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT03830853

Other Study ID Numbers:

240138

First Posted:

Feb 5, 2019

Last Update Posted:

Dec 21, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mid and South Essex NHS Foundation Trust

CTO - chronic total occlusion

OCT - optical coherence tomography

coronary physiology

absolute flow

Study Results

No Results Posted as of Dec 21, 2021