ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Condition category

Condition code

Cardiovascular

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]

Not applicable

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

3, 6 and 12 months

Primary outcome [2]

Composite of major adverse cardiovascular events (defines as death, myocardial infarction or emergent coronary revascularisation)

Timepoint [2]

3, 6 and 12 months

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Western Hospital - Footscray

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Western Health

Address [1]

Gordon Street
Footscray
Victoria. 3011

Country [1]

Australia

Primary sponsor type

Hospital

Name

Western Health

Address

Gordon Street
Footscray
Victoria. 3011

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Nadim Shah

Address [1]

c/o Western Hospital
Gordon Street
Footscray
Victoria. 3011

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital  VIC  3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/01/2014

Approval date [1]

08/04/2014

Ethics approval number [1]

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

Dr Nadim Shah

Address

c/o Western Health
Gordon Street
Footscray. 3011
Victoria

Country

Australia

Phone

+61383456666

Fax

nadim.shah@gmail.com

Contact person for public queries

Name

Nadim Shah

Address

c/o Western Health
Gordon Street
Footscray. 3011
Victoria

Country

Australia

Phone

+61383456666

Fax

nadim.shah@gmail.com

Contact person for scientific queries

Name

Nadim Shah

Address

c/o Western Health
Gordon Street
Footscray. 3011
Victoria

Country

Australia

Phone

+61383456666

Fax

nadim.shah@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Prevalence of Asymptomatic Coronary Heart Disease in the Siblings of Young Myocardial Infarction Patients as Detected by Coronary Computer Tomography Angiography: A Pilot Study.	2018	https://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.

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Documents added manually

Documents added automatically