Chronic Total Occlusion of Coronary ArteryIMPACT-CTO-2NCT03830853
The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology
An observational study of Chronic Total Occlusion of Coronary Artery, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2015to 1 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, S16 5NL
About this study
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.
Read more
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.
Read the 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.
- Keywords
- CTO - chronic total occlusion, OCT - optical coherence tomography, coronary physiology, absolute flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in coronary flow
change in coronary flow at baseline and follow up
Measured: 3 months
Change in coronary resistance
change in coronary absolute resistance at baseline and follow up
Measured: 3 months
Secondary outcomes (4)
Change in coronary anatomy
To identify intracoronary anatomical features between baseline and follow up.
Measured: 3 months
Change in exercise work load
Change in exercise work measured in METS (metabolic equivalents).
Measured: 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.
Measured: 3 months
Change in coronary pressure measurements
change in fractional flow reserve (FFR) at baseline and follow up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start23 Jan 2015
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- John Davies, MBBS, PhD, Principal investigator, Basildon and Thurrock University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830853
- Sponsor's protocol ID
- 240138
- Acronym
- IMPACT-CTO-2
- Status last verified
- Dec 2021
- First submitted
- 22 Jan 2019
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology
- ClinicalTrials.gov ID
- NCT03830853
- Acronym / sponsor ID
- IMPACT-CTO-2 / 240138
- Keywords
- CTO - chronic total occlusion, OCT - optical coherence tomography, coronary physiology, absolute flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust
- Study start
- 23 Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in coronary flow
Time frame: 3 months
change in coronary flow at baseline and follow up
Change in coronary resistance
Time frame: 3 months
change in coronary absolute resistance at baseline and follow up
4 secondary outcomes
Change in coronary anatomy
Time frame: 3 months
Change in exercise work load
Time frame: 3 months
Change in quality of life
Time frame: 3 months
Change in coronary pressure measurements
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Davies, MBBS, PhD principal investigator
Basildon and Thurrock University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion of Coronary Artery, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coronary flow (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.