Acute Coronary SyndromeIMPACT-CTONCT02643940
The Physiological Impact of CTO PCI on Coronary Pressure Measurements and Correlation in Donor Vessel
An observational study of Acute Coronary Syndrome and Coronary Artery Disease, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment options; medications, stents or potentially bypass surgery, for patients with Chronic Total Occlusion (CTO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Coronary Artery Disease
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2015to 31 May 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 scheduled for a PCI CTO
Who may be able to join
- Age >18 years of age
- Stable angina / ischaemic symptoms
- Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory
- Participant is willing and able to give informed consent for participation in the study
- Presence of a chronic total occlusion (CTO) in RCA:
- Duration of the occlusion > 3 months;
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- Thrombolysis In Myocardial Infarction (TIMI) (50) coronary flow grade 0;
- Spontaneously visible collaterals, Rentrop classification grade 1 or 2 or 3 from contralateral donor artery
- Presence of minor to intermediate coronary stenosis (1-70 %) in the contralateral donor artery
- Eligible for PCI to a chronic total occlusion (CTO)
Who cannot join
- Previous CABG with patent grafts to the interrogated donor artery
- Left main stenosis of > 40 %
- Presence of severe flow limiting stenosis in the contralateral donor artery (typically > 70 % stenosis)
- Haemodynamic instability at the time of intervention (heart rate <40 beats per minute, systolic blood pressure <90mmHg), balloon pump)
- Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
- Contraindications to PCI
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- Severe hepatic or lung disease (chronic pulmonary obstructive disease)
- Pregnancy
- ACS within 48 hours of procedure
- Severe valvular heart disease
- Severe cardiomyopathy / Infiltrative heart disease
- eGFR < 40
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
About this study
Official title: The Physiological IMPACT of Coronary Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) on Coronary Pressure --Derived Measurements, Its Correlation in the Donor Vessel and the Influence of Collateral Circulation
This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment options; medications, stents or potentially bypass surgery, for patients with Chronic Total Occlusion (CTO).
Read the detailed description
The patients in this study are planned to have a Percutaneous Coronary Intervention (PCI) with recanalization of Chronic Total Occlusion (CTO) on clinical grounds alone.
This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment option. To date there is no data available on instantaneous wave free ratio (iFR) measurement (a pressure derived assessment of flow limitation) in patients with blocked arteries.
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention (PCI), Chronic Total Occlusion (CTO), Cardiac MRI, Instantaneous wave-free ratio (iFR)
- Medical subject headings
- Acute Coronary Syndrome, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary pressure changes
Changes in coronary pressure - derived measurements (resting Pd/Pa, iFR and FFR) in donor artery pre and post RCA CTO PCI
Measured: 5 Minutes
Secondary outcomes (6)
Population correlation
Correlation between coronary pressure---derived measurements in this population.
Measured: 5 minutes
Donor artery correlation
Correlation between collateral circulation function on coronary pressure - derived measurements in donor artery pre and post RCA CTO PCI.
Measured: 5 minutes
Cardiac MRI correlation
Correlation between baseline coronary pressure - derived measurements in donor artery pre RCA CTO PCI, collateral circulation indices and baseline non-invasive functional assessment /Cardiac MRI (CMR)
Measured: 5 minutes
Effects of stenosis severity (QCA)
Effects of stenosis severity (QCA) in donor artery on coronary pressure-derived measurements
Measured: 5 minutes
Collateral circulation characteristics
Influence of collateral circulation characteristics on coronary pressure-derived measurements
Measured: 5 minutes
Coronary pressure and jeopardy scores correlation
Correlation between coronary pressure-derived measurements in the donor artery and myocardial jeopardy scores in the donor artery
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study start1 Oct 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Keeble, MBBS MRCP, Principal investigator, The Essex Cardiothoracic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643940
- Sponsor's protocol ID
- B785
- Acronym
- IMPACT-CTO
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2015
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Karamasis GV, Kalogeropoulos AS, Mohdnazri SR, Al-Janabi F, Jones R, Jagathesan R, Aggarwal RK, Clesham GJ, Tang KH, Kelly PA, Davies JR, Werner GS, Keeble TR. Serial Fractional Flow Reserve Measurements Post Coronary Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Nov;11(11):e006941. doi: 10.1161/CIRCINTERVENTIONS.118.006941.
PubMed 30571203Mohdnazri SR, Karamasis GV, Al-Janabi F, Cook CM, Hampton-Till J, Zhang J, Al-Lamee R, Dungu JN, Gedela S, Tang KH, Kelly PA, Davies JE, Davies JR, Keeble TR. The impact of coronary chronic total occlusion percutaneous coronary intervention upon donor vessel fractional flow reserve and instantaneous wave-free ratio: Implications for physiology-guided PCI in patients with CTO. Catheter Cardiovasc Interv. 2018 Sep 1;92(3):E139-E148. doi: 10.1002/ccd.27587. Epub 2018 Mar 22.
PubMed 29569332
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiological IMPACT of Coronary Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI) on Coronary Pressure --Derived Measurements, Its Correlation in the Donor Vessel and the Influence of Collateral Circulation
- ClinicalTrials.gov ID
- NCT02643940
- Acronym / sponsor ID
- IMPACT-CTO / B785
- Conditions
- Acute Coronary Syndrome, Coronary Artery Disease
- Keywords
- Percutaneous Coronary Intervention (PCI), Chronic Total Occlusion (CTO), Cardiac MRI, Instantaneous wave-free ratio (iFR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 31 Dec 2015 (estimated)
- 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.
This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment options; medications, stents or potentially bypass surgery, for patients with Chronic Total Occlusion (CTO).
Detailed description
The patients in this study are planned to have a Percutaneous Coronary Intervention (PCI) with recanalization of Chronic Total Occlusion (CTO) on clinical grounds alone.
This study will be recording pressure wire readings from both blocked and narrowed arteries, to better guide treatment option. To date there is no data available on instantaneous wave free ratio (iFR) measurement (a pressure derived assessment of flow limitation) in patients with blocked arteries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a PCI CTO
Key inclusion criteria (10 listed)
- Age >18 years of age
- Stable angina / ischaemic symptoms
- Evidence of viability and / or ischaemia in the chronic total occlusion (CTO) territory
- Participant is willing and able to give informed consent for participation in the study
- Presence of a chronic total occlusion (CTO) in RCA:
Key exclusion criteria (12 listed)
- Previous CABG with patent grafts to the interrogated donor artery
- Left main stenosis of > 40 %
- Presence of severe flow limiting stenosis in the contralateral donor artery (typically > 70 % stenosis)
- Haemodynamic instability at the time of intervention (heart rate <40 beats per minute, systolic blood pressure <90mmHg), balloon pump)
- Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
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
Coronary pressure changes
Time frame: 5 Minutes
Changes in coronary pressure - derived measurements (resting Pd/Pa, iFR and FFR) in donor artery pre and post RCA CTO PCI
6 secondary outcomes
Population correlation
Time frame: 5 minutes
Donor artery correlation
Time frame: 5 minutes
Cardiac MRI correlation
Time frame: 5 minutes
Effects of stenosis severity (QCA)
Time frame: 5 minutes
Collateral circulation characteristics
Time frame: 5 minutes
Coronary pressure and jeopardy scores correlation
Time frame: 5 minutes
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 11 Jan 2022.
- Results publication: PubMed 30571203Karamasis GV, Kalogeropoulos AS, Mohdnazri SR, Al-Janabi F, Jones R, Jagathesan R, Aggarwal RK, Clesham GJ, Tang KH, Kelly PA, Davies JR, Werner GS, Keeble TR. Serial Fractional Flow Reserve Measurements Post Coronary Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Nov;11(11):e006941. doi: 10.1161/CIRCINTERVENTIONS.118.006941.
- Results publication: PubMed 29569332Mohdnazri SR, Karamasis GV, Al-Janabi F, Cook CM, Hampton-Till J, Zhang J, Al-Lamee R, Dungu JN, Gedela S, Tang KH, Kelly PA, Davies JE, Davies JR, Keeble TR. The impact of coronary chronic total occlusion percutaneous coronary intervention upon donor vessel fractional flow reserve and instantaneous wave-free ratio: Implications for physiology-guided PCI in patients with CTO. Catheter Cardiovasc Interv. 2018 Sep 1;92(3):E139-E148. doi: 10.1002/ccd.27587. Epub 2018 Mar 22.
- 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.
Thomas Keeble, MBBS MRCP principal investigator
The Essex Cardiothoracic Centre
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 Acute Coronary Syndrome and Coronary Artery Disease, 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 10 inclusion and 12 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 11 Jan 2022. 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?
Coronary pressure changes (time frame: 5 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02643940, which also lists 2 linked publications.
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 11 Jan 2022.