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

Chronic Total Occlusion of Coronary Artery Clinical Trial

— IMPACT-CTO-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830853
• Other study ID #: 240138
• Status: Completed
• Start date: January 23, 2015
• Est. completion date: January 1, 2018

Study information

• Verified date: December 2021
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery

Locations

Country	Name	City	State
United Kingdom	The Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in coronary flow	change in coronary flow at baseline and follow up	3 months
Primary	Change in coronary resistance	change in coronary absolute resistance at baseline and follow up	3 months
Secondary	Change in coronary anatomy	To identify intracoronary anatomical features between baseline and follow up.	3 months
Secondary	Change in exercise work load	Change in exercise work measured in METS (metabolic equivalents).	3 months
Secondary	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
Secondary	Change in coronary pressure measurements	change in fractional flow reserve (FFR) at baseline and follow up	3 months