Clinical Features and Outcomes of Patients Undergoing Coronary Angiography in South Australian Public Hospitals - Coronary Angiogram Database of South Australia (CADOSA) Registry

• Register: ANZCTR
• Last refreshed on: 5 January 2021
• Main ID: ACTRN12615000026527
• Date of registration: 19/01/2015
• Prospective Registration: No
• Primary sponsor: Prof John Beltrame
• Public title: Clinical Features and Outcomes of Patients Undergoing Coronary Angiography in South Australian Public Hospitals - Coronary Angiogram Database of South Australia (CADOSA) Registry
• Scientific title: Clinical Features and Outcomes of Patients Undergoing Coronary Angiography in South Australian Public Hospitals - Coronary Angiogram Database of South Australia (CADOSA) Quality Assurance Registry
• Date of first enrolment: 01/12/2011
• Target sample size: 42000
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000026527.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Rosanna Tavella

• Name: Dr Rosanna Tavella

Key inclusion & exclusion criteria

Inclusion criteria: Undergoing coronary angiography/PCI at a South Australian teaching hospital
Exclusion criteria: Nil exclusion criteria - this registry captures all coronary angiography/PCI procedures performed in South Australian teaching hospitals

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Coronary artery disease;Chest pain;Coronary angiography;Percutaneous coronary intervention;Cardiac procedures registry;
Coronary artery disease
Chest pain
Coronary angiography
Percutaneous coronary intervention
Cardiac procedures registry

Public Health - Health service research

Cardiovascular - Coronary heart disease

Intervention(s)

The Coronary Angiogram Database of South Australia (CADOSA) is a registry of cardiac catheterisation procedures performed in the four public tertiary hospitals of South Australia (SA). This will be referred to as CADOSA-Registry. The CADOSA-Registry collects a standardised 8-page case report form (CRF) for all public coronary angiograms and percutaneous coronary interventions (PCI) performed in
the SA. The CRF is compatible with the American College of Cardiology National Cardiovascular Data Registry.

The purpose of this registry is a quality assurance measure to monitor the patients and the in-hospital care they receive undergoing angiography/PCI. This registry will also
evaluate future cardiac events (30-day & 12-month all-cause
mortality/myocardial infarction/cardiac re-admission) by analysis of administrative datasets and data linkage.
Since this is a clinical quality registry, there is no intervention or exposure for patients. The CADOSA-Registry has characteristics of clinical quality registries including:
-Collection of individual patient level data
-Collection of data from multiple sites
-Collection of treatment or care details of patients
-Collection outcome data

Primary Outcome(s)

To define the adverse event rate of patients undergoing coronary angiography/PCI as recorded in the Medical Record according to Data Specifications outlined by the American College of Cardiology National Cardiovascular Data Registry [During hospital admission for procedure]

Secondary Outcome(s)

To assess the incidence of MACE (major adverse cardiac event) over 12 months in patients undergoing coronary angiography/PCI. MACE is defined as the occurrence of cardiovascular death, non-cardiovascular death, myocardial infarction, hospitalisation for unstable angina, hospitalisation for heart failure, transient ischaemic attack or stroke. Definition for events are as follows:
Cardiovascular Death: death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes.
Non-cardiovascular death: is defined as any death that is not thought to be due to a cardiovascular cause.
Myocardial Infarction: evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
In general, the diagnosis of MI requires the combination of:
*Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and
*Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.
Unstable angina requiring hospitalization: Symptoms of myocardial ischemia at rest (chest pain or equivalent) or an accelerating pattern of angina with frequent episodes associated with progressively decreased exercise capacity prompting an unscheduled visit to a healthcare facility and hospitalization (including chest pain observation units).
Heart failure requiring hospitalisation: an admission to an inpatient unit with clinical and physical signs of heart failure with the need for additional/increased therapy.
Transient Ischemic Attack: defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction.
Stroke: defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.

The occurrence of MACE will be determined via data linkage to medical records and administrative datasets.[12 month post procedure]

To evaluate procedural appropriateness for coronary angiography/PCI according to appropriate use criteria.

Appropriate use criteria is defined by the American College of Cardiology for diagnostic catheterisation (ACCF/SCAI/AATS/AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 Appropriate Use Criteria for Diagnostic Catheterization, J Am Coll Cardiol. 2012;59(22):1-33)

and for PCI (ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT
2012 Appropriate Use Criteria for
Coronary Revascularization Focused Update, J Am Coll Cardiol. 2012 Feb 28;59(9):857-81).

These Criteria were developed in response to the need for the rational use of cardiovascular services, including imaging and invasive procedures. The Criteria provide a process to determine the appropriate use of cardiovascular procedures (cath & PCI) for selected patient indications. The Criteria rank appropriateness on a scale of 1-9, which are categorized into three groups with a respective median score being 1-3 (Inappropriate), 4-6 (Uncertain if inappropriate/appropriate) and 7-9 (Appropriate).

Procedure will have their appropriateness score calculated according to the syntax developed by the ACC. The appropriateness is determined by the data that is collected for the CADOSA-Registry. [During hospital admission for procedure]

To assess performance measures of patients undergoing coronary angiography/PCI according to the recommended guidelines.

Performance measures are defined by the American College of Cardiology/American Heart Association (ACC/AHA), Reference: ACC/AHA 2008 performance measures for adults with ST-elevation and non-ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures for ST-Elevation and Non-ST-Elevation Myocardial Infarction), J Am Coll Cardiol. 2008 Dec 9;52(24):2046-99.

The Performance Measures are indicated in Table 3 of this publication, in brief these are:
1. Aspirin at arrival
2. Aspirin prescribed at discharge
3. Beta-blockers prescribed at discharge
4. Statin at discharge
5. Evaluation of LVSF
6. ACEI or ARB for LVSD
7. Time to fibrinolytic therapy
8. Time to PCI
9. Reperfusion therapy
10. Time from ED arrival at STEMI referral facility to ED
discharge from STEMI referral facility in patients transferred for PCI
11. Time from ED arrival at STEMI referral facility to PCI
at STEMI receiving facility among transferred patients
12. Adult smoking cessation advice/counseling
13. Cardiac rehabilitation patient referral from an inpatient
setting
T-1. LDL-C assessment
T-2. Excessive initial heparin dose
T-3. Excessive initial enoxaparin dose
T-4. Excessive initial abciximab dose
T-5. Excessive initial eptifibatide dose
T-6. Excessive initial tirofiban dose
T-7. Anticoagulant dosing protocol (structural measure)
T-8. Anticoagulant error tracking system (structural measure)
T-9. Clopidogrel at discharge.

Performances measures are assessed by collating and analysing the data collected from the CADOSA-Registry. [During hospital admission for procedure]

Secondary ID(s)

Nil

Source(s) of Monetary Support

The South Australian Cardiovascular Research Development Program

Ethics review

Status: Approved
Approval date: 18/04/2011
Contact:

Human Research Ethics Committee (TQEH/LMH/MH)

Status: Approved
Approval date: 01/06/2011
Contact:

Southern Adelaide Clinical Research Ethics Committee

Status: Approved
Approval date: 17/08/2011
Contact:

Royal Adelaide Hospital Research Ethics Comittee