Study to Detect Biomarker Gradients in Coronary Arteries Using the Liquid Biopsy System

NCT02119767 | Completed

• 1 other identifier: CE002
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Coronary Heart Disease

Keywords

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• Clinical outcome of detected coronary gradients (by telephone for all patients)

  3 years 8 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• PlaqueTec Ltd: lead
• Papworth Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridgeshire, PE28 9QT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Coronary Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Nick West, MD

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

GB (1)