Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000403235
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
20/03/2018
Date last updated
20/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of coronary blood flow in patients with severe aortic stenosis treated with transcatheter aortic valve replacement
Scientific title
Evaluation of coronary flow reserve in patients with severe aortic stenosis treated with transcatheter aortic valve replacement
Secondary ID [1] 294246 0
None.
Universal Trial Number (UTN)
Trial acronym
COAST study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 306927 0
Condition category
Condition code
Cardiovascular 306025 306025 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with severe aortic stenosis who are referred for transcatheter aortic valve replacement (TAVR) will have baseline CT coronary angiography (with CT FFR). At the time of TAVR, they will undergo invasive coronary physiological measurements (including pressure and flow) at baseline and hyperaemia, immediately before and after valve deployment. At 6-9 months follow up, they will have repeat CT coronary angiography (with CT FFR) and invasive coronary physiological measurements. Coronary flow reserve will be derived from the acquired indices.
Intervention code [1] 300544 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305058 0
The primary endpoint of this study will be the change in coronary flow reserve pre- and post- valve implantation as measured by invasive coronary physiological assessment.
Timepoint [1] 305058 0
Baseline and 6 months
Secondary outcome [1] 344021 0
- Changes in CT-derived fractional flow reserve
Timepoint [1] 344021 0
Baseline and 6 months

Eligibility
Key inclusion criteria
1) Patients with severe aortic stenosis requiring transcatheter aortic valve implantation
2) age greater than or equal to 18 years and less than or equal to 84 years
3) able to provide informed consent
Minimum age
18 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) patients with significant coronary artery stenosis mandating clinically indicated revascularisation
2) previous myocardial infarction
3) previous ischaemic or haemorrhagic stroke
4) chronic renal impairment, as defined by estimated glomerular filtration rate of less than or equal to 45ml/min/1.73m2
5) previous coronary artery bypass surgery
6) left ventricular ejection fraction <50% or known regional wall motion abnormality on echocardiography
7) atrial fibrillation
8) uncontrolled hypertension, as defined by a pre-procedural blood pressure of >150/90mmHg
9) pharmacologically-treated diabetes mellitus
10) decompensated heart failure
11) severe asthma or resting bradycardia precluding use of adenosine
12) unfavourable coronary anatomy that would prohibit safe guidewire passage
13) women of childbearing age.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary endpoint of the proposed study will be the change in coronary flow reserve (CFR) values from baseline to six-months following TAVR. CFR and other invasive physiological data will be regarded as continuous variables. Continuous data will be presented as mean (+/- SD) or median (interquartile range), as appropriate. As physiological variables patient will be available for each patient before and after TAVR, comparisons will be made using a paired Students t-test or Wilcoxon signed-rank test, as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10272 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 10273 0
Jessie McPherson Private Hospital - Clayton
Recruitment postcode(s) [1] 21939 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 298885 0
University
Name [1] 298885 0
Monash University
Country [1] 298885 0
Australia
Primary sponsor type
Hospital
Name
MonashHeart
Address
MonashHeart
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Victoria
3168
Country
Australia
Secondary sponsor category [1] 298100 0
None
Name [1] 298100 0
Address [1] 298100 0
Country [1] 298100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299827 0
Monash Health Ethics Committee
Ethics committee address [1] 299827 0
Monash Health
Monash Medical Centre
246 Clayton Road
Clayton
Victoria
3168
Ethics committee country [1] 299827 0
Australia
Date submitted for ethics approval [1] 299827 0
14/11/2017
Approval date [1] 299827 0
01/03/2018
Ethics approval number [1] 299827 0
HREC/17/MonH/549

Summary
Brief summary
Aortic stenosis is the commonest valve pathology requiring medical intervention. Aortic stenosis causes restriction and alterations in blood flow to the rest of the body including the coronary arteries which can cause symptoms of fatigue, breathlessness, chest pain and dizziness. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure where a new valve is inserted inside the old narrowed valve using a balloon catheter. This can relieve the symptoms as blood can once again be pumped freely to the rest of the body without the additional effort. Existing data suggests that this procedure allows partial restoration of normal blood flow to the coronary arteries. However, it remains unclear what the longer term effects of this procedure are. This an important consideration as it will enable us to have a better understanding of this treatment. We aim to conduct assessment in 30 patients undergoing TAVR using cardiac CT, echocardiography and coronary flow measurements around the index procedure and at 6-9 months follow up. We expect to see that there is further restoration of normal coronary physiology at follow up after TAVR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81694 0
Dr Adam J. Brown
Address 81694 0
Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168
Country 81694 0
Australia
Phone 81694 0
+61 3 9594 2726
Fax 81694 0
+61 3 9594 6939
Email 81694 0
[email protected]
Contact person for public queries
Name 81695 0
Dr Michael Michail
Address 81695 0
Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168
Country 81695 0
Australia
Phone 81695 0
+61 3 9594 2726
Fax 81695 0
+61 3 9594 6939
Email 81695 0
[email protected]
Contact person for scientific queries
Name 81696 0
Dr Michael Michail
Address 81696 0
Monash Cardiovascular Research Centre
Department of Medicine
Monash University
246 Clayton Road
Clayton
Victoria
3168
Country 81696 0
Australia
Phone 81696 0
+61 3 9594 2726
Fax 81696 0
+61 3 9594 6939
Email 81696 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdaptations to Coronary Physiology in a Patient With Severe Aortic Stenosis and Complete Heart Block Undergoing Transcatheter Aortic Valve Replacement.2019https://dx.doi.org/10.1016/j.jcin.2019.01.215
N.B. These documents automatically identified may not have been verified by the study sponsor.