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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
Trial website
Trial related presentations / publications
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

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


Results not provided in https://clinicaltrials.gov/study/NCT00403351