Registry to provide contemporary information regarding characteristics, management and outcomes of outpatients with stable coronary artery disease

• Register: ISRCTN
• Last refreshed on: 23 January 2023
• Main ID: ISRCTN43070564
• Date of registration: 13/06/2011
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: Registry to provide contemporary information regarding characteristics, management and outcomes of outpatients with stable coronary artery disease
• Scientific title: ProspeCtive observational LongitudinAl RegIstry oF patients with stable coronary arterY disease
• Date of first enrolment: 01/11/2009
• Target sample size: 33000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN43070564
• Study type: Observational
• Study design: Multicentre prospective observational longitudinal study (Screening)
• Phase: Not Applicable

Countries of recruitment

Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Korea, South, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Oman, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Thailand, Ukraine, United Arab Emirates, United Kingdom, Viet Nam

Contacts

• Name: Philippe Gabriel Steg

Key inclusion & exclusion criteria

Inclusion criteria: Outpatients with stable coronary artery disease, proven by history of at least one of the following criteria:
1. Documented myocardial infarction (more than 3 months ago)
2. Coronary stenosis of more than 50% proven by coronary angiography
3. Chest pain with proven myocardial ischemia
4. Coronary artery bypass grafting surgery or percutaneous coronary intervention (more than 3 months ago)
Exclusion criteria: 1. Patients hospitalised for cardiovascular disease within last 3 months
2. Patients with planned revascularisation
3. Conditions hampering the participation or the 5-year follow-up

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary artery disease
Circulatory System
Coronary artery disease

Intervention(s)

The registry attempted to collect representative data for each of the participating countries. Representativeness is ensured by a two-tiered process:
1. Determination of physician type in charge of outpatients with stable CAD in a given country and targeting of an appropriate proportion of each of this physician's specialties
2. For each physician, enrollment of consecutive, eligible patients. The data will be collected prospectively using an electronic standardised international case report form (translated into the local language) at baseline and annually during 5 years follow up (at 12+/-3, 24+/-3, 36+/-3, 48+/-3, and 60+/-3 months).

Primary Outcome(s)

Information collected at baseline will include demographics, medical history, risk factors, employment status, physical examination, heart rate, laboratory values (if available), and current chronic medical treatments. Each annual follow-up visit will collect information regarding clinical events, hospitalisations, interventions, death, employment status, physical examination, heart rate, laboratory values (if available) and current medical therapy (cardiovascular and non-cardiovascular).

Secondary Outcome(s)

No secondary outcome measures

Secondary ID(s)

N/A

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

National Research Ethics Service, Isle of Wight, Portsmouth and Southeast Hampshire Research Ethics Committee, UK approved on 20/11/2009. All other centres obtained ethics approval before recruitment of the first participant.

Results

• Results available: Yes
• Date Completed: 30/07/2015