NCT02975518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2018

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

November 23, 2016

Last Update Submit

July 15, 2021

Conditions

Endothelial Progenitor CellsCoronary Artery DiseaseVascular InjuryCoronary Angiography

Outcome Measures

Primary Outcomes (1)

  • Standard uptake value

    Standard-uptake values of injured sections of artery will be compared to remote uninjured artery

    0-4 hours

Study Arms (4)

Intra-venous infusion of Flourodeoxyglucose

ACTIVE COMPARATOR

As a control for radio labelled cells, Flourodeoxyglucose will be administered intra-venously at an activity equal to that injected with the labelled endothelial cells.

Biological: Administration of radio labelled endothelial outgrowth cells

Intra-Arterial infusion of Flourodeoxyglucose

ACTIVE COMPARATOR

As a control for radio labelled cells, Flourodeoxyglucose will be administered intra-arterially at an activity equal to that injected with the labelled endothelial cells.

Biological: Administration of radio labelled endothelial outgrowth cells

Intra-venous injection of radio-labelled endothelial cells

EXPERIMENTAL

Endothelial cells labelled with flourodeoxyglucose will be injected intra-venously with their distribution tracked using PET CT.

Biological: Administration of radio labelled endothelial outgrowth cells

Intra-Arterial injection of radio-labelled endothelial cells

EXPERIMENTAL

Endothelial cells labelled with flourodeoxyglucose will be injected intra-arterially with their distribution tracked using PET CT.

Biological: Administration of radio labelled endothelial outgrowth cells

Interventions

Administration of radio labelled endothelial outgrowth cellsBIOLOGICAL

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.

Intra-Arterial infusion of FlourodeoxyglucoseIntra-Arterial injection of radio-labelled endothelial cellsIntra-venous infusion of FlourodeoxyglucoseIntra-venous injection of radio-labelled endothelial cells

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing coronary angiography for known or suspected ischaemic heart disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH74DL, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery DiseaseVascular System Injuries

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

December 1, 2015

Primary Completion

March 12, 2018

Study Completion

March 12, 2018

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

GB(1)