Skip to content

Tracking Endothelial Cells in Arterial Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02975518
Enrollment
36
Registered
2016-11-29
Start date
2015-12-31
Completion date
2018-03-12
Last updated
2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Angiography, Coronary Artery Disease, Endothelial Progenitor Cells, Vascular Injury

Brief summary

We plan to track the migratory behaviour of culture-expanded enothelial outgrowth cells in the context of vascular injury sustained during elective coronary angiography. We will use Flouro-deoxyglucose-labelling and PET-CT to track the endothelial cells.

Detailed description

The radial artery is commonly injured following trans-radial cardiac catheterisation and this injury can be demonstrated as a reduction in endothelial function as measured by flow-mediated dilatation which recovers with time (13-15). Thus the radial artery is useful as a model of mechanical arterial injury as radial artery trauma is common and endothelial function can be followed longitudinally with a non-invasive test. Endothelial progenitor cells localise to sites of arterial injury in animal models both in vitro and in vivo and accelerate re-endothelialisation as well as attenuating neointimal hyperplasia (16-18), This has however not been demonstrated in man. Our research group, in collaboration with the Scottish Blood Transfusion Service (SNBTS) have developed a good manufacturing practice (GMP)-compliant process for manufacturing an endothelial progenitor cell (EPC) product (SNBTS will manufacture the final product administered to patients). We have also demonstrated in vitro that we can label these cells with the radioisotope 18 F-fluorodeoxyglucose (18F-FDG) and that activity can be detected in as few as 200 cells using a hybrid positron emission and computed tomography (PET-CT) scanner (Biograph mCT Siemens Medical Systems, Erlangen, Germany). We will therefore be able to track the fate of these cells in vivo. The major potential advantage of imaging in this way is that only 18F-FDG associated with EPCs will be delivered to the patient, removing the issue of background attenuation due to free circulating 18F-FDG. A similar technique has previously been employed in vivo to track homing of unselected autologous bone marrow cells to infarcted myocardium(19). Following intracoronary delivery using this technique, the authors were able to detect 1.3% - 2.6% of 18F-FDG-labelled cells in the infarcted myocardium. Demonstrating that EPCs are able to home to and integrate at sites of vascular injury in man is a critical step in understanding the role of EPCs in vascular repair

Interventions

BIOLOGICALAdministration of radio labelled endothelial outgrowth cells

Radio labelled endothelial outgrowth cells will be administered to patients undergoing elective coronary angiography and stenting. They will be administered intra-venously and intra-arterially (right radial artery) in separate arms. Migratory behaviour of these cells will be defined using PET CT. Intra-venous and intra-arterial injection of free radio tracer will serve as a control comparator arms.

Sponsors

British Heart Foundation
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing coronary angiography for known or suspected ischaemic heart disease

Exclusion criteria

1. Previous coronary artery bypass surgery. 2. Planned angiography via the femoral artery as a sole arterial access route 3. Anaemia \<10g/L 4. Severe valvular heart disease 5. Acute myocardial infarction within previous three months 6. Cardiac failure (Killip class ≥II). 7. Insulin dependent diabetes mellitus 8. Hepatic failure (Childs-Pugh grades B or C). 9. Renal failure (estimated glomerular filtration rate \<25 mL/min). 10. Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy. 11. Women of child-bearing age not ensuring reliable methods of contraception. 12. Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Standard uptake value0-4 hoursStandard-uptake values of injured sections of artery will be compared to remote uninjured artery

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026