Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04901767 |
| Other study ID # |
262024 (207-11-19) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2021 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Norfolk and Norwich University Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Use of intracoronary acetylcholine to investigate endothelial function in coronary arteries
treated with either drug coated balloon angioplasty of drug eluting stents.
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 administration. This will be measured with incremental doses of acetylcholine
at levels both proximally and distally to the site of treatment Also is to see how far
endothelial dysfunction may propagate from an interventional site by measuring drug induced
dilatation/constriction as in response to acetylcholine administration. This vasomotor
response will be measured in the target vessel at extended distances from the treated
segment.
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.
