Coronary Artery Endothelial Dysfunction With Drug Coated Balloons

NCT04901767 | Completed

• 1 other identifier: 262024 (207-11-19)
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Use of intracoronary acetylcholine to investigate endothelial function in coronary arteries treated with either drug coated balloon angioplasty of drug eluting stents.

Conditions

Coronary Artery Disease; Ischaemic Heart Disease; Endothelial Dysfunction

Keywords

Percutaneous coronary intervention; Drug coated balloons; Drug eluting stents

Outcome Measures

Primary Outcomes (1)

• Fractional change in coronary artery diameter and surface area within treated segment

  Will be expressed as a percentage. I.e. we will measure the diameter in mm and area in mm2 before and after.

  3-6 months

Secondary Outcomes (1)

• Fractional change in coronary artery diameter and surface area with increments from area of treatment

  3-6 months

Study Arms (2)

Receiving drug coated balloon (DCB)

Receiving drug eluting stent (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be included who have received percutaneous coronary intervention with either a drug coated balloon or drug eluting stent and stable symptoms. Patients who have a clinically indicated procedure will be eligible to be recruited as participants. They must also fulfil the inclusion criteria and not be affected by any of the exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator

Study Sites (1)

Norfolk & Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

Related Links

• Dysfunction\&lt;/b\&gt; Int Heart J \[Internet\]. 2007;48(5):553-67.
• Koskinas KC, Chatzizisis YS, Antoniadis AP, Giannoglou GD. Role of Endothelial Shear Stress in Stent Restenosis and Thrombosis. J Am Coll Cardiol \[Internet\]. 2012;59(15):1337-49.
• Ohtsuka M, Yokoyama S, Imaizumi T, Mitsutake Y, Toyama Y, Chibana H, et al. Coronary Endothelial Dysfunction Distal to Stent of First-Generation Drug-Eluting Stents. JACC Cardiovasc Interv \[Internet\]. 2012;5(9):966-73.
• Ho HH, Ong PJL. BASKET-SMALL 2: advancing DCB beyond in-stent restenosis. Lancet \[Internet\]. 2018;392(10150):802-4.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ioannis Dr Merinopoulos

  IOANNIS.MERINOPOULOS@nnuh.nhs.uk

  STUDY CHAIR

• Vassilis Dr Vassiliou

  VASSILIOS.VASSILIOU@nnuh.nhs.uk

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: March 23, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-11

Locations

GB (1)