Coronary Artery DiseaseNCT02437734
Virtual Coronary Physiology: an Angiogram is All You Need
A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Disease in coronary arteries kills more people in the UK than any other cause. The investigators have developed a computer system ('VIRTU') which predicts blood pressure changes inside coronary arteries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2013to 31 Oct 2016
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable symptoms of coronary ischemia
- Coronary angiographic findings of significant or borderline coronary lesions of any morphology
- Potentially suitable for PCI
Who cannot join
- Critical ischemia
- Significant valvular heart disease
- Bleeding diathesis
- Terminal cancer
- Pregnancy 6. Lack of informed consent
- Chronic total occlusion of target vessel
Show all 10Show fewer
- Acute presentation in the previous 60 days
- Intolerance of adenosine, nitrate, iodine based contrast media
- Inability to take dual antiplatelet therapy
- Target vein graft.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
About this study
Disease in coronary arteries kills more people in the UK than any other cause. The investigators have developed a computer system ('VIRTU') which predicts blood pressure changes inside coronary arteries. This is important because;
- Doctors make better decisions regarding when and how to treat patients with coronary artery disease if they have these blood pressure measurements
- Currently, Doctors have to insert a metal wire inside the heart to measure artery pressures which is time-consuming and requires special equipment, staff, training and medicines.
Read more
Although this invasive technique saves lives and money, more than 95% of patients do not receive the procedure or the benefits it provides.
VIRTU provides a solution to this problem since it only needs X-ray pictures and does not require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and works but needs improving before it can be used in all patients.
GOALS:
Following, and compared with, our pilot project ((Modelling the significance of coronary artery disease, STH 15740) to:
- Improve VIRTU's accuracy.
- Improve VIRTU's speed.
- Test VIRTU in patients with more complicated coronary disease.
One hundred patients will be recruited from angiography waiting lists and consented before attending for their angiography. The patients will be asked whether their angiogram pictures and pressure measurements maybe used as part of the data collection for this study. The data will be used to validate and develop VIRTU to make it 'patient-ready'. VIRTU will deliver all the advantages of the current invasive technique (i.e. reduced deaths, heart attacks and cost) but, is less invasive and usable in 100% patients.
Read the detailed description
- Plan of Investigation Several interacting workstreams will proceed in parallel in this observational, analytical, 36-month study between the University of Sheffield (UoS), Sheffield Teaching Hospitals NHS Foundation Trust (STH), and our collaborators at King's College London (KCL). This protocol document outlines the methodology for clinical data collection from patients attending STH. These (fully anonymised) clinical data will then be used to validate and optimise the use of VIRTU by improving its accuracy and speed as well as developing a user-friendly interface. The development work will take place within the UoS and KCL, with no impact on NHS patient, staff or premises after the clinical data collection described below (these subsequent workstreams are detailed in Appendix 1).
- Study design A phase II, observational, analytical study of coronary angiography and computational fluid dynamics in 100 adults with coronary artery disease undergoing coronary angiography.
- Methodology (Workstream 1) Clinical data will be collected from the Cardiac Catheter Laboratory (CCL) at STH in a similar manner to which was performed in a pilot project. Therefore, the feasibility of recruitment targets and modelling techniques to be used in this study have already been demonstrated. In this current study, 100 patients with stable CAD of any pattern/severity, potentially suitable for PCI, will be recruited. Potential participants will be identified by a member of the care team from pre-admission clinic lists in the cardiac catheter laboratory at the time of diagnostic angiography or referral from another Cardiologist. These patients will be sent a patient information sheet. If they are interested in finding out more about the study, the patients will meet with the Research Nurse or Doctor to discuss the project in more detail and ask questions. At the pre-admission clinic the Research Nurse or Doctor will take informed consent from those patients willing to participate and complete the study recruitment log and the Clinical Details section of the Data Collection Form. The patients will then attend for their scheduled PCI at the Northern General Hospital at a later date (usually 2 -3 weeks after the pre-admission clinic). Details of the clinical procedure are below. During the PCI a member of the research team (Dr Gunn, Dr Morton, Dr Morris or Research Nurse) will record the arterial diagrams and procedure details on the second part of the anonymised Data Collection Form.
- Clinical Procedure Selected patients will be asked to undergo cardiac magnetic resonance imaging before and after PCI, using a standardised protocol. All clinical and angiographic techniques are in routine NHS clinical practice. No experimental techniques will be used. Pre- and post procedure care will not alter from routine elective PCI care. The PCI will proceed as normal where indicated, using best contemporary practice, including premedication. The study methods are in routine use for many patients undergoing PCI; and include rotational coronary angiography and pressure wire deployment to assess the physiological significance of lesions. This study merely requires that they be used systematically using standardised methodology. Rotational coronary angiography will be recorded in standard single axis rotations (cranial and caudal for left coronary; plane PA for right coronary). An intravenous bolus of 200mcg GTN will be given prior to each run. They will be done on a breath hold, with a rapid hand injection of 10-20mL of contrast. Also, standard, single plane, orthogonal, carefully selected, angiograms will be recorded to guide the procedure. These will be performed at baseline and after stent deployment. All major epicardial diseased vessels will be interrogated with a pressure wire (Volcano Corporation). An infusion of adenosine (140mcg/kg/min) will be set up and attached to the intravenous cannula in the hand/arm. The pressure wire will be calibrated against the guide catheter pressure, with the introducing needle removed. The wire will then be advanced across the lesion(s). A bolus of 200mcg GTN will be given and then the iv adenosine infusion started (repeated as necessary since adenosine has very short half life). When the pressures have stabilised, the baseline pressure and flow velocity will be recorded as the wire is withdrawn, while imaging, at 1cm/sec. Stent implantation will proceed according to the clinical judgment of the operator, using both the angiographic appearance and the pressure gradient (Fractional Flow Reserve) across any lesions of interest as arbiters. Standard criteria will be used; namely a stenosis that appears to be >50% diameter stenosis in 2 orthogonal projections by eye (or >70% in one) and/or an FFR <0.80. The choice of stent will be at the discretion of the operator. After stent deployment, the rotational angiograms and pressure wire pullback will be repeated, using the methods described above. In the case of multi-vessel disease, the pullback will be repeated for the 2nd and the 3rd vessels.
- Setting for the project Clinical data collection will happen over a 30 month period within Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital. Cardiac Catheter Laboratory will be used for all procedures, because it possesses single axis rotational angiography.
- Patient population One hundred patients will be recruited from PCI waiting lists.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
A phase II, observational, analytical study of coronary angiography and computational fluid dynamics in 100 adults with coronary artery disease undergoing coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| Coronary angiography | Other | Selected patients will be asked to undergo Coronary angiography with cardiac magnetic resonance imaging before and after Percutaneous Coronary Intervention. Clinical data collection will happen over a 30 month period. Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracoronary blood pressures
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start13 Aug 2013
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Nana Theodorou, Study chair, STH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437734
- Sponsor's protocol ID
- STH16467
- Status last verified
- Apr 2017
- First submitted
- 30 Apr 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Coronary Physiology: an Angiogram is All You Need
- ClinicalTrials.gov ID
- NCT02437734
- Acronym / sponsor ID
- STH16467
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 8 May 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.
Disease in coronary arteries kills more people in the UK than any other cause. The investigators have developed a computer system ('VIRTU') which predicts blood pressure changes inside coronary arteries. This is important because;
- Doctors make better decisions regarding when and how to treat patients with coronary artery disease if they have these blood pressure measurements
- Currently, Doctors have to insert a metal wire inside the heart to measure artery pressures which is time-consuming and requires special equipment, staff, training and medicines.
Although this invasive technique saves lives and money, more than 95% of patients do not receive the procedure or the benefits it provides.
VIRTU provides a solution to this problem since it only needs X-ray pictures and does not require any wires, drugs, or additional time, equipment or staff. VIRTU has been tested and works but needs improving before it can be used in all patients.
GOALS:
Following, and compared with, our pilot project ((Modelling the significance of coronary artery disease, STH 15740) to:
- Improve VIRTU's accuracy.
- Improve VIRTU's speed.
- Test VIRTU in patients with more complicated coronary disease.
One hundred patients will be recruited from angiography waiting lists and consented before attending for their angiography. The patients will be asked whether their angiogram pictures and pressure measurements maybe used as part of the data collection for this study. The data will be used to validate and develop VIRTU to make it 'patient-ready'. VIRTU will deliver all the advantages of the current invasive technique (i.e. reduced deaths, heart attacks and cost) but, is less invasive and usable in 100% patients.
Detailed description
- Plan of Investigation Several interacting workstreams will proceed in parallel in this observational, analytical, 36-month study between the University of Sheffield (UoS), Sheffield Teaching Hospitals NHS Foundation Trust (STH), and our collaborators at King's College London (KCL). This protocol document outlines the methodology for clinical data collection from patients attending STH. These (fully anonymised) clinical data will then be used to validate and optimise the use of VIRTU by improving its accuracy and speed as well as developing a user-friendly interface. The development work will take place within the UoS and KCL, with no impact on NHS patient, staff or premises after the clinical data collection described below (these subsequent workstreams are detailed in Appendix 1).
- Study design A phase II, observational, analytical study of coronary angiography and computational fluid dynamics in 100 adults with coronary artery disease undergoing coronary angiography.
- Methodology (Workstream 1) Clinical data will be collected from the Cardiac Catheter Laboratory (CCL) at STH in a similar manner to which was performed in a pilot project. Therefore, the feasibility of recruitment targets and modelling techniques to be used in this study have already been demonstrated. In this current study, 100 patients with stable CAD of any pattern/severity, potentially suitable for PCI, will be recruited. Potential participants will be identified by a member of the care team from pre-admission clinic lists in the cardiac catheter laboratory at the time of diagnostic angiography or referral from another Cardiologist. These patients will be sent a patient information sheet. If they are interested in finding out more about the study, the patients will meet with the Research Nurse or Doctor to discuss the project in more detail and ask questions. At the pre-admission clinic the Research Nurse or Doctor will take informed consent from those patients willing to participate and complete the study recruitment log and the Clinical Details section of the Data Collection Form. The patients will then attend for their scheduled PCI at the Northern General Hospital at a later date (usually 2 -3 weeks after the pre-admission clinic). Details of the clinical procedure are below. During the PCI a member of the research team (Dr Gunn, Dr Morton, Dr Morris or Research Nurse) will record the arterial diagrams and procedure details on the second part of the anonymised Data Collection Form.
- Clinical Procedure Selected patients will be asked to undergo cardiac magnetic resonance imaging before and after PCI, using a standardised protocol. All clinical and angiographic techniques are in routine NHS clinical practice. No experimental techniques will be used. Pre- and post procedure care will not alter from routine elective PCI care. The PCI will proceed as normal where indicated, using best contemporary practice, including premedication. The study methods are in routine use for many patients undergoing PCI; and include rotational coronary angiography and pressure wire deployment to assess the physiological significance of lesions. This study merely requires that they be used systematically using standardised methodology. Rotational coronary angiography will be recorded in standard single axis rotations (cranial and caudal for left coronary; plane PA for right coronary). An intravenous bolus of 200mcg GTN will be given prior to each run. They will be done on a breath hold, with a rapid hand injection of 10-20mL of contrast. Also, standard, single plane, orthogonal, carefully selected, angiograms will be recorded to guide the procedure. These will be performed at baseline and after stent deployment. All major epicardial diseased vessels will be interrogated with a pressure wire (Volcano Corporation). An infusion of adenosine (140mcg/kg/min) will be set up and attached to the intravenous cannula in the hand/arm. The pressure wire will be calibrated against the guide catheter pressure, with the introducing needle removed. The wire will then be advanced across the lesion(s). A bolus of 200mcg GTN will be given and then the iv adenosine infusion started (repeated as necessary since adenosine has very short half life). When the pressures have stabilised, the baseline pressure and flow velocity will be recorded as the wire is withdrawn, while imaging, at 1cm/sec. Stent implantation will proceed according to the clinical judgment of the operator, using both the angiographic appearance and the pressure gradient (Fractional Flow Reserve) across any lesions of interest as arbiters. Standard criteria will be used; namely a stenosis that appears to be >50% diameter stenosis in 2 orthogonal projections by eye (or >70% in one) and/or an FFR <0.80. The choice of stent will be at the discretion of the operator. After stent deployment, the rotational angiograms and pressure wire pullback will be repeated, using the methods described above. In the case of multi-vessel disease, the pullback will be repeated for the 2nd and the 3rd vessels.
- Setting for the project Clinical data collection will happen over a 30 month period within Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital. Cardiac Catheter Laboratory will be used for all procedures, because it possesses single axis rotational angiography.
- Patient population One hundred patients will be recruited from PCI waiting lists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary angiography | Other | Procedure: Percutaneous Coronary InterventionSelected patients will be asked to undergo Coronary angiography with cardiac magnetic resonance imaging before and after Percutaneous Coronary Intervention. Clinical data collection will happen over a 30 month period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stable symptoms of coronary ischemia
- Coronary angiographic findings of significant or borderline coronary lesions of any morphology
- Potentially suitable for PCI
Key exclusion criteria (10 listed)
- Critical ischemia
- Significant valvular heart disease
- Bleeding diathesis
- Terminal cancer
- Pregnancy 6. Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary InterventionA phase II, observational, analytical study of coronary angiography and computational fluid dynamics in 100 adults with coronary artery disease undergoing coronary angiography. | Procedure or surgery | Coronary angiography |
Primary outcome
Intracoronary blood pressures
Time frame: 2 hours
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 25 Apr 2017.
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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.
Nana Theodorou study chair
STH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Sheffield Teaching Hospitals 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 10 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 25 Apr 2017. 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?
Intracoronary blood pressures (time frame: 2 hours). 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 25 Apr 2017.