Status:
COMPLETED
Coronary Artery Endothelial Dysfunction With Drug Coated Balloons
Lead Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of East Anglia
Conditions:
Coronary Artery Disease
Ischaemic Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
Use of intracoronary acetylcholine to investigate endothelial function in coronary arteries treated with either drug coated balloon angioplasty of drug eluting stents.
Detailed Description
The primary objective is to establish the differences in vasomotor response of a DCB and DES treated artery by measurement of the percentage change in coronary surface area pre and post acetylcholine ...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Been treated with percutaneous coronary intervention of either drug coated balloon or drug eluting stent
Exclusion
- Any contraindications to administration of acetylcholine or GTN
- History of coronary vasospasm or spontaneous coronary artery dissection
- Significant medical, surgical or psychiatric disease that would affect subject safety or influence the study outcome according to physician's opinion
- Patients who received a combination of drug eluting stents and drug coated balloon to the same vessel
- Significant renal impairment (estimated glomerular filtration rate \<30mL/min/ 1.73m2
- Body mass index \>35 (may affect coronary artery diameter qualitative assessment)
- Symptomatic congestive cardiac failure
- Severe asthma
- Significant autoimmune inflammatory conditions (for example rheumatoid arthritis)
- Patients taking immunomodulating drugs (including Methotrexate, Ciclosporin, steroids)
- Previous heart transplant
- Relative Anaemia - Haemoglobin \<12g/dL in men and \<10g/dL in women
- Women of child bearing age with a positive pregnancy test
Key Trial Info
Start Date :
March 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04901767
Start Date
March 23 2021
End Date
February 1 2022
Last Update
December 21 2023
Active Locations (1)
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1
Norfolk & Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY