Coronary Artery Endothelial Dysfunction With Drug Coated Balloons
NCT ID: NCT04901767
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2021-03-23
2022-02-01
Brief Summary
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Detailed Description
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To achieve a meaningful comparison, 34 patients will be recruited of which 17 patients would form either arm of the study having had either a DCB or DES.
The study will be performed at the Norfolk and Norwich University Hospital and patients will be enrolled prior to a second procedure. This may occur immediately after their stent or drug coated balloon treatment or if they re-attend hospital in the following recruitment period and this may include patients for a variety of different indications.
Patients who have a scheduled, 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.
A member of the research team will provide the Patient Information Sheet to potential participants and confirm that they would be happy to be contacted subsequently to discuss the proposed research. The subsequent contact will be undertaken by a clinical research fellow, who is both a member of the Norfolk and Norwich University Hospital NHS clinical team as well as the research team, prior to their subsequent visit to discuss the study, answer any questions and confirm if they fulfil the inclusion criteria. In view of Covid-19, to reduce in hospital exposure, we might instead opt to send the patient information to the eligible patients by post, and follow with a telephone call to confirm receipt.
Method: Patients will be prepared in the usual way as per clinical practice for their procedure. They will attend via a standardised case pathway depending on the indication for repeat angiography (staged procedure versus re-presentation acutely for another reason such as chest discomfort). There are a series of routine checks performed to ensure that the patient is on appropriate medications. For the purpose of the study, anti-anginal medications will need to be stopped for 72 hours prior to the procedure. The anti-anginal medications that would require cessation include:
* Cardio selective Beta 1 selective blockers (Atenolol, Bisoprolol, Carvedilol, Esmolol, Metoprolol and Nebivolol )
* Diltiazem
* Nicorandil
* Isosorbide Nitrate preparations
* Ranolazine The particular medication regime will vary on a patient to patient basis and the appropriateness of this and nature of drug cessation will be discussed at the enrolment process and patients will be given clear instruction on adjustments to their regimen.
Coronary Angiography will be performed as per common clinical practice. At the beginning of the study portion of the procedure, there will be two orthogonal angiographic views taken of the treated segment which will then be denoted as the reference views for the rest of the procedure (used after every administration of agonist).
Acetylcholine (ACh) will be diluted into 0.9% normal saline at different dilutions (to a total volume of 5mL). NB - these solutions of Acetylcholine are usable within a two-hour period, beyond this time a new solution should be used. When reassessing the previously treated artery, an infusion of intracoronary acetylcholine will be administered via the guiding catheter. The first ACH infusion ("low dose") will be 0.182micrograms/mL (10\^-6mol/L) given at a rate of 1Ml/min for two minutes by a mechanical infusion pump (50). After the infusion, intracoronary contrast will be injected and images acquired.
If there are no adverse features, the investigator can proceed with the subsequent increments with each infusion to complete, followed by a five-minute interval. The next increments would be:
* "medium dose" 1.82mcg/ml (10\^-5mol/L) ACH in 5ml normal saline - given over 20 seconds.
* "high dose" 18.2mcg/ml (10\^-4mol/l) ACH in 5ml normal saline - given over 20 seconds.
* Then after a further five minutes - a bolus dose of GTN (400mcg) will be administered over 20 seconds and then a further contrast acquisition taken within two minutes. Also see Appendix C for lab flow chart.
Once these images have been taken, the guide catheter will be removed the procedure will then be completed in the usual way. The patient with then be moved to the appropriate recovery area as per the standard protocol following PCI procedures.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Receiving drug coated balloon (DCB)
No interventions assigned to this group
Receiving drug eluting stent (DES)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Male or Female, aged 18 years or above.
* Been treated with percutaneous coronary intervention of either drug coated balloon or drug eluting stent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of East Anglia
OTHER
Norfolk and Norwich University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Locations
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Norfolk & Norwich University Hospital
Norwich, Norfolk, United Kingdom
Countries
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Related Links
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Dysfunction\</b\> 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.
Other Identifiers
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262024 (207-11-19)
Identifier Type: -
Identifier Source: org_study_id