Coronary Heart DiseaseCS1NCT02119767
Study to Detect Biomarker Gradients in Coronary Arteries Using the Liquid Biopsy System
An observational study of Coronary Heart Disease, run by PlaqueTec Ltd at 1 site in United Kingdom.
Trial summary
The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood directly from coronary arteries. These arteries supply blood to muscles of the heart and can become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Feb 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: Subjects will be recruited at secondary care cardiology facilities. All subjects who need a percutaneous transluminal interventional coronary procedure (excluding those with an ST elevation myocardial infarction) will be considered for this study. Potential participants will be identified from pre-admission clinic lists and screened for suitability by members of the clinical team. Eligible patients will be approached for participation in the study.
Who may be able to join
- Subjects that are candidates for percutaneous transluminal interventional coronary procedures
- Subjects undergoing elective PCI
- Subjects presenting for PCI after NSTEMI
- Subjects who have been preloaded with dual antiplatelet therapy (aspirin and clopidogrel (or prasugrel or ticagrelor)) as per usual local PCI practice.
- Subjects who are willing and able to sign an informed consent.
Who cannot join
- Subjects for whom the LBS is contra-indicated:
- The LBS is contraindicated for use in severely stenosed, excessively tortuous or calcified coronary vessels.
- The LBS is contraindicated in coronary vessels with a reference diameter of less than 2.5 mm.
- The LBS is contraindicated for use in regions of coronary vessels that contain a stent.
- The LBS is contraindicated for use in the carotid arteries, cerebral vessels or any of their side branches.
- The LBS is contraindicated for use with patients in whom anticoagulant or antiplatelet therapy is contraindicated, or have uncorrected bleeding disorders or an allergy to heparin.
Show all 21Show fewer
- Use of the LBS is contraindicated in patients with ongoing sepsis that is considered relevant to cardiac catheterization.
- The LBS is contraindicated for use in the acute phase of an ST Segment Elevation Myocardial Infarction, in patients with severe hemodynamic instability or shock.
- The LBS is contraindicated for use in the presence of angiographic evidence of intracoronary thrombus.
- Subjects who are unwilling or unable to sign an informed consent
- Subjects undergoing immunosuppressive therapies
- Severe left ventricular dysfunction (left ventricular ejection fraction <30%)
- Cardiogenic shock
- PCI target in left main stem
- PCI target lesion with low pre-procedure chance of success or high pre-procedure risk of complication (e.g. chronic total occlusion, thrombus load)
- Subjects <18 years (there is no upper age limit but there is a requirement that patients are considered to be "fit" enough by the operating cardiologist for the LBS procedure to not cause significant additional risk)
- Pregnancy
- Contraindication to dual antiplatelet therapy or inability to take dual antiplatelet therapy for at least 4 weeks post-procedure
- Serum creatinine above 125 µmol/L.(i.e. the upper limit for normal)
- Subjects on warfarin at the time of procedure
- Subjects with active chronic inflammatory disease, e.g. systemic lupus erythematosus, rheumatoid arthritis, seropositive arthropathies and known seropositivity to HIV, Hepatitis B or Hepatitis C.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridgeshire, PE28 9QT
About this study
The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood directly from coronary arteries. These arteries supply blood to muscles of the heart and can become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Recent research has shown that development of ' plaques' inside coronary arteries is controlled by chemicals (biomarkers) released into the blood from damaged areas of the artery wall. The LBS is designed to collect blood samples at the exact site of plaque formation. By testing these blood samples for biomarkers of plaque formation, it is hoped that new diagnostic tests and treatments for heart disease may be developed. The proposed investigation is use the LBS in humans to detect these biomarkers. The safety of the LBS has already been demonstrated in both human and animal studies. The study will enroll 70 patients with coronary artery disease who are undergoing routine percutaneous coronary intervention (PCI). PCI is a procedure used to open up a blocked coronary artery. It uses a catheter on the end of which is a special balloon that is inflated inside the blocked artery to open up the vessel and restore blood flow. A small metal spring (stent) is usually inserted to keep the blood vessel open. This study will test if the LBS device, when used just prior to a PCI procedure, can detect biomarkers released by diseased coronary arteries. The study will also determine if the presence of these biomarkers is linked to the long term health of the patient. The study will take place at Papworth Hospital, over a period of approximately 8 months (including telephone based patient followup calls 30 days, 6 months, 1, 2 and 3 years after the procedure to determine patient health).
Read the detailed description
The purpose of this Clinical Investigation is to use the PlaqueTec Liquid Biopsy System (LBS) to determine which biomarkers detected locally within the coronary artery can give information on the state of atherosclerotic disease. The LBS is a novel CE-marked class III coronary catheter designed for sampling blood directly from the coronary arteries. The LBS is unique in that it can capture "gradients" of biological molecules within the coronary artery and by analysing the samples it collects it can unequivocally identify which biomarkers have been locally released within the coronary artery. The samples can then be analysed for a variety of biomarkers using standard analytical techniques. Cardiologists should find this of great benefit as recent studies have shown that coronary artery disease is controlled and directed by the release of specific biological molecules into the blood from diseased areas of the coronary arteries. The safety and performance of the LBS has been proved previously in a recent First In Man study. The Clinical Investigation study will enroll 70 patients and will be observational in nature. The study is designed to use the device in its intended application (i.e. as an adjunct to a PCI procedure, such as the deployment of a stent) and to collect biomarker gradients released locally within the coronary artery. It will then follow up on the health status of the patients and see if the release of certain biomarkers is associated with particular clinical outcomes. The device will be used to look for locally released biomarkers at two different stages of the deployment of a stent, i.e. before and after its deployment. The first stage is prior to the deployment of the stent and the LBS will collect blood samples to look for the release of "natural" biomarkers gradients, i.e. those biomarkers that are naturally released during the progression and development of diseased regions within the artery. The second stage is to use the LBS to collect blood samples across a diseased artery that has just be perturbed (by "pre-ballooning", a procedure carried out just prior to stent insertion) and will looked for "induced" biomarker gradients, i.e. those molecules that are released by a diseased plaque when it ruptures. The insights gained by collecting biomarker gradients at these two stages will give very important information on what causes a region of artery to become diseased and how diseased portions of the artery affect the blood and cause heart attacks. The samples that are collected by the LBS in the above clinical settings will be analysed for a series of biomarker gradients previously selected by PlaqueTec' s Scientific Advisory Panel (SAP) for their potential role in causing atherosclerosis. The data collected by the LBS will be for research only and will not be used to affect the patient treatment. In summary, the LBS study will deliver completely new insights into coronary artery disease and will significantly increase the understanding of this hugely significant disease. Patients who need an elective percutaneous transluminal interventional coronary procedure will be considered for this study. Patients requiring emergency interventional procedures will be excluded. The study duration is estimated to be about 8 months with a three year follow up period.
- Conditions
- Coronary Heart Disease
- Keywords
- Atherosclerosis
- Medical subject headings
- Coronary Disease, Atherosclerosis
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 |
|---|---|---|
| Natural gradients | Patients requiring an elective PCI who present with either non-ST-segment elevation myocardial infarction (NSTEMI) or chronic stable angina who will have natural gradients sampled using the LBS | |
| Induced gradients | Patients requiring an elective PCI who present with either non-ST-segment elevation myocardial infarction (NSTEMI) or chronic stable angina who will have induced gradients sampled using the LBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local release of biomarkers by diseased regions of the coronary artery
That biomarkers are released locally by diseased regions of the coronary artery (either naturally or during pre-ballooning for stenting) of patients with cardiovascular disease (CVD) and detectable using the LBS and associated assays
Measured: 2 years
Secondary outcomes (1)
Clinical outcome of detected coronary gradients (by telephone for all patients)
This will test whether the local release of biomarkers detected by the LBS has an association with clinical outcome. Clinical outcome will be assessed for all patients (between 40 and 70 patients will be included in this study) by telephone follow-up.
Measured: 3 years 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PlaqueTec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Papworth Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Nick West, MD, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119767
- Sponsor's protocol ID
- CE002
- Acronym
- CS1
- Status last verified
- Feb 2022
- First submitted
- 17 Apr 2014
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Detect Biomarker Gradients in Coronary Arteries Using the Liquid Biopsy System
- ClinicalTrials.gov ID
- NCT02119767
- Acronym / sponsor ID
- CS1 / CE002
- Conditions
- Coronary Heart Disease
- Keywords
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- PlaqueTec LtdIndustry (pharma, biotech, devices)
- Collaborators
- Papworth Hospital NHS Foundation Trust
- Study start
- Jul 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 22 Apr 2014 (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.
The Liquid Biopsy System (LBS) is a new catheter (thin tube) designed for sampling blood directly from coronary arteries. These arteries supply blood to muscles of the heart and can become blocked by 'plaques' leading to chest pain (angina) and heart attacks. Recent research has shown that development of ' plaques' inside coronary arteries is controlled by chemicals (biomarkers) released into the blood from damaged areas of the artery wall. The LBS is designed to collect blood samples at the exact site of plaque formation. By testing these blood samples for biomarkers of plaque formation, it is hoped that new diagnostic tests and treatments for heart disease may be developed. The proposed investigation is use the LBS in humans to detect these biomarkers. The safety of the LBS has already been demonstrated in both human and animal studies. The study will enroll 70 patients with coronary artery disease who are undergoing routine percutaneous coronary intervention (PCI). PCI is a procedure used to open up a blocked coronary artery. It uses a catheter on the end of which is a special balloon that is inflated inside the blocked artery to open up the vessel and restore blood flow. A small metal spring (stent) is usually inserted to keep the blood vessel open. This study will test if the LBS device, when used just prior to a PCI procedure, can detect biomarkers released by diseased coronary arteries. The study will also determine if the presence of these biomarkers is linked to the long term health of the patient. The study will take place at Papworth Hospital, over a period of approximately 8 months (including telephone based patient followup calls 30 days, 6 months, 1, 2 and 3 years after the procedure to determine patient health).
Detailed description
The purpose of this Clinical Investigation is to use the PlaqueTec Liquid Biopsy System (LBS) to determine which biomarkers detected locally within the coronary artery can give information on the state of atherosclerotic disease. The LBS is a novel CE-marked class III coronary catheter designed for sampling blood directly from the coronary arteries. The LBS is unique in that it can capture "gradients" of biological molecules within the coronary artery and by analysing the samples it collects it can unequivocally identify which biomarkers have been locally released within the coronary artery. The samples can then be analysed for a variety of biomarkers using standard analytical techniques. Cardiologists should find this of great benefit as recent studies have shown that coronary artery disease is controlled and directed by the release of specific biological molecules into the blood from diseased areas of the coronary arteries. The safety and performance of the LBS has been proved previously in a recent First In Man study. The Clinical Investigation study will enroll 70 patients and will be observational in nature. The study is designed to use the device in its intended application (i.e. as an adjunct to a PCI procedure, such as the deployment of a stent) and to collect biomarker gradients released locally within the coronary artery. It will then follow up on the health status of the patients and see if the release of certain biomarkers is associated with particular clinical outcomes. The device will be used to look for locally released biomarkers at two different stages of the deployment of a stent, i.e. before and after its deployment. The first stage is prior to the deployment of the stent and the LBS will collect blood samples to look for the release of "natural" biomarkers gradients, i.e. those biomarkers that are naturally released during the progression and development of diseased regions within the artery. The second stage is to use the LBS to collect blood samples across a diseased artery that has just be perturbed (by "pre-ballooning", a procedure carried out just prior to stent insertion) and will looked for "induced" biomarker gradients, i.e. those molecules that are released by a diseased plaque when it ruptures. The insights gained by collecting biomarker gradients at these two stages will give very important information on what causes a region of artery to become diseased and how diseased portions of the artery affect the blood and cause heart attacks. The samples that are collected by the LBS in the above clinical settings will be analysed for a series of biomarker gradients previously selected by PlaqueTec' s Scientific Advisory Panel (SAP) for their potential role in causing atherosclerosis. The data collected by the LBS will be for research only and will not be used to affect the patient treatment. In summary, the LBS study will deliver completely new insights into coronary artery disease and will significantly increase the understanding of this hugely significant disease. Patients who need an elective percutaneous transluminal interventional coronary procedure will be considered for this study. Patients requiring emergency interventional procedures will be excluded. The study duration is estimated to be about 8 months with a three year follow up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural gradients | – | –Patients requiring an elective PCI who present with either non-ST-segment elevation myocardial infarction (NSTEMI) or chronic stable angina who will have natural gradients sampled using the LBS |
| Induced gradients | – | –Patients requiring an elective PCI who present with either non-ST-segment elevation myocardial infarction (NSTEMI) or chronic stable angina who will have induced gradients sampled using the LBS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited at secondary care cardiology facilities. All subjects who need a percutaneous transluminal interventional coronary procedure (excluding those with an ST elevation myocardial infarction) will be considered for this study. Potential participants will be identified from pre-admission clinic lists and screened for suitability by members of the clinical team. Eligible patients will be approached for participation in the study.
Key inclusion criteria (5 listed)
- Subjects that are candidates for percutaneous transluminal interventional coronary procedures
- Subjects undergoing elective PCI
- Subjects presenting for PCI after NSTEMI
- Subjects who have been preloaded with dual antiplatelet therapy (aspirin and clopidogrel (or prasugrel or ticagrelor)) as per usual local PCI practice.
- Subjects who are willing and able to sign an informed consent.
Key exclusion criteria (21 listed)
- Subjects for whom the LBS is contra-indicated:
- Subjects who are unwilling or unable to sign an informed consent
- Subjects undergoing immunosuppressive therapies
- Severe left ventricular dysfunction (left ventricular ejection fraction <30%)
- Cardiogenic shock
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
Local release of biomarkers by diseased regions of the coronary artery
Time frame: 2 years
That biomarkers are released locally by diseased regions of the coronary artery (either naturally or during pre-ballooning for stenting) of patients with cardiovascular disease (CVD) and detectable using the LBS and associated assays
1 secondary outcome
Clinical outcome of detected coronary gradients (by telephone for all patients)
Time frame: 3 years 8 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 2 Mar 2022.
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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.
Nick West, MD principal investigator
Papworth Hospital NHS Foundation Trust
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 Coronary Heart Disease, run by PlaqueTec Ltd 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 5 inclusion and 21 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 2 Mar 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?
Local release of biomarkers by diseased regions of the coronary artery (time frame: 2 years). 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 2 Mar 2022.