Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000441011
Ethics application status
Approved
Date submitted
26/05/2010
Date registered
1/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of Myocardial Fibrosis by Cardiac Magnetic Resonance relaxometry
Scientific title
Detection of Myocardial Fibrosis by Cardiac Magnetic Resonance relaxometry in apparently healthy volunteers versus patients with high blood pressure with normal/ abnormal cardiac function
Secondary ID [1] 251870 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MYOCARDIAL FIBROSIS 257465 0
Condition category
Condition code
Cardiovascular 257613 257613 0 0
Normal development and function of the cardiovascular system
Cardiovascular 257614 257614 0 0
Hypertension
Cardiovascular 257615 257615 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fibrosis tissue accumulation is an integral feature of the adverse structural remodelling of cardiac tissue seen with hypertensive heart disease. Given the importance of fibrosis tissue in leading to myocardial dysfunction and failure.
The volunteers and patients will undergo an Magnetic resonance imaging (MRI) for one time only.
MRI is a painless non-invasive technique that involves lying in a scanner to create image based on magnetic signal of the protons inside the human body.
Cardiac MRI relaxometry has variuos techniques, which includes standard magnetic resonance imaging (MRI) sequences including tagging, Modified Look-Locker Inversion recovery imaging (MOLLI), to early detection of myocardial fibrosis. These technique have ability to assess abnormal structure and function of the heart. The scanning takes about 20 to 25 minutes for normal volunteers and the patients takes about 45 Minutes due to repeat of MRI technique after 8 minutes delay injection of MRI contrast agent. The patients will be injected by MRI contrast agent (Gadolinium) to assess any possibility of scarring tissue in the myocardium.
Then, the MRI result will correlate with echocardiography and histopathology findings.
Intervention code [1] 256555 0
Early detection / Screening
Comparator / control treatment
A)- 50 healthy subjects,
b)- 100 patients with high blood pressure with normal (50) and abnormal (50) cardiac function,
c)- and 50 patients undergoing bypass surgery

All groups will undergo the same MRI protocols. The patients group will indergo the same technique plus injection of Gadolinium contrast agent to assess possibility of myocardial infarction. The Gadolinium is a safer standard clinical MRI contrast agent and the Gadolinium dose will Intravenously (I.V) administration at rate of 0.15 mmol/Kg.
Control group
Active

Outcomes
Primary outcome [1] 258523 0
By using the MRI techniques, we can achieve two different contrast appearance of the heart, T1 and T2 star weighted imaging.
T1 and T2 star relaxation time of the heart can be measured by analyses the image with offline software e.g. MRmap software. this software allow us to measure the value of relaxation time in a seconds.
then, T1 and T2 star relaxation time of normal myocardium can be quantified.
Timepoint [1] 258523 0
assessed at a once scan time.
Secondary outcome [1] 264348 0
the hypertensive group will undergo with same MRI technique to assess any Alteration of relaxation times for early fibrosis.
Timepoint [1] 264348 0
assessed at a once scan time.

Eligibility
Key inclusion criteria
The patient cohort (OVER 40 YEARS) will comprise apparently healthy patients and patients with high blood pressure with normal and abnormal cardiac function recruited from the hospital clinic and the community
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1)- Women who are pregnant and the human fetus.
2)- Children and/or young people (i.e. <40 years).
3)- People with an intellectual or mental impairment.
4)- People highly dependent on medical care.
5)- People in existing dependent or unequal relationships with any member of the research team, the researcher(s), and/or the person undertaking the recruitment /consent process.
6)- A history of drug abuse that would interfere with the ability to comply with the study protocol.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The patient cohort will comprise apparently healthy volunteers and patients with high blood pressure with normal and abnormal cardiac function recruited from the hospital clinics and the community.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
a)- 50 healthy subjects,
b)- 100 patients with high blood pressure with normal (50) and abnormal (50) cardiac function,
c)- and 50 patients undergoing bypass surgery.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257051 0
University
Name [1] 257051 0
the University of Queensland
Country [1] 257051 0
Australia
Primary sponsor type
University
Name
the University of Queensland
Address
The Centre for Advanced Imaging
University of Queensland,
St Lucia, QLD, 4072
Australia
Country
Australia
Secondary sponsor category [1] 256310 0
Government body
Name [1] 256310 0
Ministry of Higher Education - Kingdom of Saudi Arabia
Address [1] 256310 0
Cultural Mission of Royal Embassy of Saudi Arabia
P.O. BOX 1206
DICKSON , ACT, 2602
Australia
Country [1] 256310 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259079 0
METRO SOUTH HEALTH SERVICE DISTRICT HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 259079 0
Ethics committee country [1] 259079 0
Australia
Date submitted for ethics approval [1] 259079 0
10/10/2009
Approval date [1] 259079 0
11/05/2010
Ethics approval number [1] 259079 0
HREC/09/QPAH/277

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31224 0
Address 31224 0
Country 31224 0
Phone 31224 0
Fax 31224 0
Email 31224 0
Contact person for public queries
Name 14471 0
QURAIN ALSHAMMARI
Address 14471 0
The University of Queensland -
Southern School of Medicine - Princess Alexandra Hospital,
Ipswich Rd Woolloongabba
QLD 4102
Country 14471 0
Australia
Phone 14471 0
+61 7 3176 5216
Fax 14471 0
+61 7 3176 5399
Email 14471 0
[email protected]
Contact person for scientific queries
Name 5399 0
Qurain Alshammari
Address 5399 0
The University of Queensland -
Southern School of Medicine - Princess Alexandra Hospital,
Ipswich Rd Woolloongabba
QLD 4102
Country 5399 0
Australia
Phone 5399 0
+61731765340
Fax 5399 0
+61 7 3176 5399
Email 5399 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.