Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000156987
Ethics application status
Approved
Date submitted
9/02/2011
Date registered
9/02/2011
Date last updated
15/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Myocardial tissue characterisation in left ventricular hypertrophy using echocardiography and cardiac magnetic resonance.
Scientific title
Myocardial tissue characterisation in left ventricular hypertrophy using echocardiography and cardiac magnetic resonance.
Secondary ID [1] 253545 0
None
Universal Trial Number (UTN)
U1111-1119-2838
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 261103 0
Systemic Hypertension 261104 0
Condition category
Condition code
Cardiovascular 259238 259238 0 0
Hypertension
Cardiovascular 259239 259239 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Echocardiogram will be performed to measure strain and diastolic cardiac function. Cardiac Magnetic Resonance Imaging will be performed to measure myocardial fibrosis and perfusion reserve . These tests will take approximately 90 minutes, and will performed once only in each patient, from either the aortic stenosis cohort, the systemic hypertension cohort or the healthy subjects.
Intervention code [1] 257973 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262088 0
To determine whether the differences seen in LV hypertrophy in aortic stenosis by echocardiography and Cardiac MRI parameters of complex heart motion and tissue characterisation differentiate it from other forms of pathological hypertrophy.
Timepoint [1] 262088 0
Echocardiography and Cardiac MRI on enrollment.
Primary outcome [2] 262089 0
To determine whether the differences seen in left ventricular hypertrophy in systemic hypertension by echocardiography and Cardiac MRI parameters of complex heart motion and tissue characterisation differentiate it from other forms of pathological hypertrophy.
Timepoint [2] 262089 0
Echocardiography and Cardiac MRI on enrollment.
Secondary outcome [1] 273132 0
None
Timepoint [1] 273132 0
Nil

Eligibility
Key inclusion criteria
Cohort 1. Patients with history of aortic stenosis.
Cohort 2. patients with history of systemic hypertension
Cohort 3. healthy subjects, no history of AS or hypertension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known cardiovascular disease
Known peripheral vascular disease
Hypercholesterolemia (total cholesterol > 6mmol/L)
Diabetes (type I or II)
Metabolic syndrome and a BMI of < 30
Standard MRI contraindications, including permanent pacemaker, implantable defibrillator, severe claustrophobia.
Renal impairment (eGFR < 60ml/min) will be an exclusion criterion from the administration of gadolinium

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258429 0
Hospital
Name [1] 258429 0
Flinders Medical Centre
Country [1] 258429 0
Australia
Primary sponsor type
Individual
Name
Professor Joesph Selvanayagam
Address
Department Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country
Australia
Secondary sponsor category [1] 257577 0
None
Name [1] 257577 0
Address [1] 257577 0
Country [1] 257577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260413 0
The Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 260413 0
Human Research Ethics
Southern Adelaide Health Service
SA Health
Room 2A221 - Inside Human Resources
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 260413 0
Australia
Date submitted for ethics approval [1] 260413 0
18/01/2011
Approval date [1] 260413 0
28/01/2011
Ethics approval number [1] 260413 0
22/11/2011

Summary
Brief summary
This research project composes of collecting echocardiographic and cardiac MRI (CMR) data on two populations of patients; those with severe aortic stenosis and those with systemic hypertension and comparing them to healthy subjects. We would like to use the data collected on these two cohorts of patients to look at 2 dimensional strain imaging, tissue Doppler imaging, three dimensional volumes and myocardial fibrosis. By using these advanced imaging techniques we can evaluate and quantify left ventricular (LV) hypertrophy and myocardial characteristics. This may give us a better understanding of cardiac remodelling and the function of the heart muscle in each of these disease states. We hypothesise that differences in myocardial function and tissue characterisation detected by these imaging techniques may be detected in patients aortic stenosis and hypertension with similar degrees of LV hypertrophy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32170 0
Address 32170 0
Country 32170 0
Phone 32170 0
Fax 32170 0
Email 32170 0
Contact person for public queries
Name 15417 0
Kate Schwartz
Address 15417 0
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 15417 0
Australia
Phone 15417 0
+61 8 8201 7700
Fax 15417 0
+61 8 8201 7701
Email 15417 0
[email protected]
Contact person for scientific queries
Name 6345 0
Amy Penhall
Address 6345 0
Department Cardiovascular Investigations
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country 6345 0
Australia
Phone 6345 0
+61 8 8404 2004
Fax 6345 0
Email 6345 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
No additional documents have been identified.