Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00403351




Registration number
NCT00403351
Ethics application status
Date submitted
22/11/2006
Date registered
23/11/2006
Date last updated
2/09/2020

Titles & IDs
Public title
Alternative Risk Markers in Coronary Artery Disease (ARMCAD)
Scientific title
Correlation of Multiple Risk Factors With Presence and Severity of Coronary Artery Disease.
Secondary ID [1] 0 0
CP-02/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 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
ARM-CAD 1 - Cross-sectional analysis using coronary angiogram results

ARM-CAD 2 - Prospective cohort for incident cardiovascular events and mortality
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Extent and severity of angiographic coronary artery disease
Timepoint [1] 0 0
cross-sectional
Primary outcome [2] 0 0
All-cause death or myocardial infarction
Timepoint [2] 0 0
1, 2, 5 years
Primary outcome [3] 0 0
All-cause death, MI or need for cardiac surgery
Timepoint [3] 0 0
1, 2, 5 years
Secondary outcome [1] 0 0
All-cause death
Timepoint [1] 0 0
1, 2, 5 years

Eligibility
Key inclusion criteria
* Adults (18 years or older)
* Male or Female
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute coronary syndrome
* Urgent angiography
* Assessment would constitute harm to patient
* Informed consent not obtained

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
665
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Box Hill Hospital (Eastern Health) - Box Hill
Recruitment hospital [2] 0 0
Caulfield General Medical Centre - Caulfield
Recruitment hospital [3] 0 0
Northern Hospital (Northern Health) - Epping
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
- Caulfield
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Brompton & Harefield NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
IM Medical Ltd, Melbourne
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Estimating the risk of future cardiovascular events such as death, stroke and myocardial infarction using traditional risk factors (such as age, gender, smoking, diabetes, hyperlipidaemia and hypertension) is well accepted in patients with and without existing cardiovascular disease. These estimates are based on a number of robust observational studies, including the original Framingham study. While these methods apply reasonably well on a population level their application to the individual patients is not always straightforward. In addition, risk charts, such as those published by the Joint British Societies and American Heart Association, may underestimate risk in certain groups, notably diabetics and patients of Indo-Asian background, whilst overestimating risk in others (by as much as 50% in some studies).
Trial website
https://clinicaltrials.gov/study/NCT00403351
Trial related presentations / publications
Kotecha D, Flather M, McGrady M, Pepper J, New G, Krum H, Eccleston D. Contemporary predictors of coronary artery disease in patients referred for angiography. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):280-8. doi: 10.1097/HJR.0b013e3283310108.
Kotecha D, New G, Flather MD, Eccleston D, Pepper J, Krum H. Five-minute heart rate variability can predict obstructive angiographic coronary disease. Heart. 2012 Mar;98(5):395-401. doi: 10.1136/heartjnl-2011-300033. Epub 2011 Nov 25.
Kotecha D, New G, Collins P, Eccleston D, Krum H, Pepper J, Flather MD. Radial artery pulse wave analysis for non-invasive assessment of coronary artery disease. Int J Cardiol. 2013 Aug 10;167(3):917-24. doi: 10.1016/j.ijcard.2012.03.098. Epub 2012 Apr 4.
Kotecha D, Flather MD, Atar D, Collins P, Pepper J, Jenkins E, Reid CM, Eccleston D; Alternative Risk Markers in Coronary Artery Disease (ARM-CAD) Study. B-type natriuretic peptide trumps other prognostic markers in patients assessed for coronary disease. BMC Med. 2019 Apr 3;17(1):72. doi: 10.1186/s12916-019-1306-9.
Public notes

Contacts
Principal investigator
Name 0 0
Dipak Kotecha, MB ChB PhD
Address 0 0
Monash University, Royal Brompton Hospital & University of Birmingham
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00403351