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Completed

NCT Number: NCT03830853

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

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.

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Key information

Conditions

Chronic Total Occlusion of Coronary Artery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Essex Cardiothoracic Centre

Basildon, Essex, S16 5NL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in coronary flow

    Time frame: 3 months

    change in coronary flow at baseline and follow up

  2. Change in coronary resistance

    Time frame: 3 months

    change in coronary absolute resistance at baseline and follow up

Secondary outcomes

  1. Change in coronary anatomy

    Time frame: 3 months

    To identify intracoronary anatomical features between baseline and follow up.

  2. Change in exercise work load

    Time frame: 3 months

    Change in exercise work measured in METS (metabolic equivalents).

  3. Change in quality of life

    Time frame: 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.

  4. Change in coronary pressure measurements

    Time frame: 3 months

    change in fractional flow reserve (FFR) at baseline and follow up

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Collaborators

  • Brighton and Sussex University Hospitals NHS Trust

Registry information

Acronym: IMPACT-CTO-2

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 5, 2019
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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