Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000105640
Ethics application status
Approved
Date submitted
21/01/2014
Date registered
29/01/2014
Date last updated
27/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The frequency of heart artery disease in the siblings of young heart attack patients and the utility of using computer topography (CT) heart scans as a screening test to detect heart artery disease.
Scientific title
The prevalence of asymptomatic coronary heart disease in the siblings of young myocardial infarction patients and the utility of coronary CT angiography as a screening tool.
Secondary ID [1] 283940 0
Nil
Universal Trial Number (UTN)
U1111-1152-4695
Trial acronym
Screening for Asymptomatic Coronary Heart disease in the Siblings of young Myocardial Infarction patients (SACHSMI): A Pilot Study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 290962 0
Condition category
Condition code
Cardiovascular 291306 291306 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Stress echocardiography - increase heart rate with exercise or dobutamine. Heart ultrasound scan before and after increasing the heart rate. Will take approximately 30 minutes.
Coronary CT angiography - injection of intravenous contrast followed by CT scan of the heart arteries. Will take approximately 30 minutes.
Each test will be undertaken in all participants on 2 different occasions within 1 week of each other.
Intervention code [1] 288635 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291300 0
Proportion of participants with mild, moderate and severe coronary heart disease as detected on coronary CT angiography.
This will be compared with findings of stress echocardiography and also with cardiovascular risk scoring tools (Framingham, Interheart and SCORE).
Timepoint [1] 291300 0
3, 6 and 12 months
Primary outcome [2] 291301 0
Composite of major adverse cardiovascular events (defines as death, myocardial infarction or emergent coronary revascularisation)
Timepoint [2] 291301 0
3, 6 and 12 months
Secondary outcome [1] 306465 0
Angina - this will be assessed via written questionnaire. It is yet to be prepared but will be specifically for this study. It has not been validated.
Timepoint [1] 306465 0
3, 6 and 12 months

Eligibility
Key inclusion criteria
Young asymptomatic individuals (male with age between 30-55 and female with age between 30-60) with a history of an acute MI (AMI) in a sibling before 55 years of age for both sexes will be recruited.
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinical exclusion criteria are known history of CHD (positive findings on previous functional test or invasive coronary angiogram, history of prior MI or coronary revascularisation), age younger than 30 for both sexes, age older than 55 for male and 60 for female, and refusal to consent. Individuals with contrast or Dobutamine allergy, chronic renal impairment (eGFR <60 mls/min), atrial fibrillation or frequent ventricular ectopics, thyrotoxicosis, pregnancy, ventricular pacing, left bundle branch block or known severe valvular disease will be excluded.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The prevalence of clinically significant CHD as defined by the CCTA criteria above and the primary and secondary clinical endpoints will be analyzed with descriptive statistics. The association between study endpoints (clinically significant CHD and primary and secondary clinical endpoints) and all the biomarkers will be analyzed using binary logistic regression for dichotomous outcomes and linear regression analysis for endpoints with continuous variables (e.g. coronary calcium score). The sensitivity, specificity, positive and negative predictive values of stress echocardiography will be calculated using CCTA as a reference standard.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
17/06/2014
Date of last participant enrolment
Anticipated
3/07/2015
Actual
11/08/2015
Date of last data collection
Anticipated
Actual
15/08/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1982 0
Western Hospital - Footscray

Funding & Sponsors
Funding source category [1] 288581 0
Hospital
Name [1] 288581 0
Western Health
Country [1] 288581 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Gordon Street
Footscray
Victoria. 3011
Country
Australia
Secondary sponsor category [1] 287291 0
Individual
Name [1] 287291 0
Dr Nadim Shah
Address [1] 287291 0
c/o Western Hospital
Gordon Street
Footscray
Victoria. 3011
Country [1] 287291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290445 0
Melbourne Health
Ethics committee address [1] 290445 0
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 290445 0
Australia
Date submitted for ethics approval [1] 290445 0
29/01/2014
Approval date [1] 290445 0
08/04/2014
Ethics approval number [1] 290445 0
2014.002

Summary
Brief summary
Heart artery disease (also known as coronary heart disease), which can lead to heart attacks, remains the leading cause of death in Australia. A significant proportion of heart attacks have been shown to be among those deemed ‘young’. This study aims to determine if siblings of young heart attack patients are likely to have significant coronary heart disease themselves even if they currently have no symptoms of it. If this were true then they maybe at an increased risk of suffering a heart attack or dying compared to the general population. This study will also explore whether currently available heart artery disease risk scoring tools are significantly less accurate in predicting the presence of CHD compared to computerised tomography (CT scan) of the heart arteries. If this is found to be true then it may establish CT as a screening test to allow early detection of coronary heart disease by visualising the heart arteries.

Hence the aims are as follows:
1.To determine what proportion of siblings of young heart attack patients have coronary heart disease themselves.
2.To compare how accurate heart ultrasound scans during exercise (stress echo) are as compared to CT scans.
3.To investigate the accuracy of popular heart artery disease risk scoring tools: Framingham, Interheart and SCORE.
4.To determine the clinical outcomes of the participants who have coronary heart disease detected on their CT scans.

Design and Methodology:
We are aiming involve 50 siblings of young heart attack patients in this pilot study. All participants will undergo blood tests for cholesterol levels, stress echo and CT scans of the heart. Their probability of having coronary heart disease will be calculated using the aforementioned risk scoring tools. The reliability of these risk scoring tools will be compared with the findings of CT scan. The end point of the study will be two fold. Firstly, the findings of CT scan, stress echo and risk scoring tool will be compared and the proportion of participants with coronary heart disease (as detected by CT) will be determined. Secondly, participants will be followed with telephone calls for 30 days, 6 months and 12 months for any event of chest pain, hospitalisation for cardiac problem, heart attack or death. Their outcomes will be compared with their test results.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45722 0
Dr Nadim Shah
Address 45722 0
c/o Western Health
Gordon Street
Footscray. 3011
Victoria
Country 45722 0
Australia
Phone 45722 0
+61383456666
Fax 45722 0
Email 45722 0
[email protected]
Contact person for public queries
Name 45723 0
Dr Nadim Shah
Address 45723 0
c/o Western Health
Gordon Street
Footscray. 3011
Victoria
Country 45723 0
Australia
Phone 45723 0
+61383456666
Fax 45723 0
Email 45723 0
[email protected]
Contact person for scientific queries
Name 45724 0
Dr Nadim Shah
Address 45724 0
c/o Western Health
Gordon Street
Footscray. 3011
Victoria
Country 45724 0
Australia
Phone 45724 0
+61383456666
Fax 45724 0
Email 45724 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
EmbasePrevalence of Asymptomatic Coronary Heart Disease in the Siblings of Young Myocardial Infarction Patients as Detected by Coronary Computer Tomography Angiography: A Pilot Study.2018https://dx.doi.org/10.1016/j.hlc.2017.03.160
N.B. These documents automatically identified may not have been verified by the study sponsor.