Secondary Coronary Prevention Clinical Trial
Official title:
The NOR-COR (NORwegian CORonary) Study: Identification of CHD Patients With Poor Adherence to Secondary Prevention and Their Perceived Needs for Follow-up
| Verified date | June 2015 |
| Source | Vestre Viken Hospital Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Regional Ethics Commitee |
| Study type | Observational |
The NOR-COR study is a cross-sectional, observational study designed to explore a large
number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors
(including anxiety, depression, quality of life) in 1369 patients with established coronary
heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen
(n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and
laboratory data, and sputum/saliva for genetic analyses will be collected.
The main overall aim of the NOR-COR study is to develop new strategies to improve secondary
prevention for underserved high risk patient-groups with CHD. The first study phase aims to
collect information necessary to develop empirically based future secondary coronary
prevention interventions. In a genetic sub-project markers associated with CHD and
personality type will be explored.
The study will evaluate current secondary preventive programs and explore the mechanisms
that link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The
study will in short term provide new knowledge potentially useful for increasing
participation in current cardiac rehabilitation/secondary preventive programs. For a longer
perspective these associations may be useful for design of new intervention programs to
selected high risk patient groups whom may be in need of programs with different content
and/or of longer duration than those currently being applied.
| Status | Completed |
| Enrollment | 975 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion criteria: All patients aged 18-80 years with first or recurrent diagnosis or treatments for CHD: a) acute myocardial infarction [ICD-10; I21], b) coronary artery by-pass graft operation (CABG), or c) elective or emergency PCI [ICD-10; I25]) have been identified from hospital patient discharge lists (diagnostic lists) by searching chronologically after last admission the past three years. In patients with recurrent diagnosis the last event will define the event. Exclusion Criteria: - Cognitive impairment that would invalidate assessment including all patients living at nursing home and psychosis. - Short life expectancy (i.e. <1 year) due to terminal heart (NYHA class 4), lung (chronic obstructive pulmonary disease GOLD 4)-, liver- or kidney disease (chronic kidney disease stage 5), malignant disease, or other reason. - Not able to understand and write the Norwegian language or refuse to give written informed consent to study participation. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Norway | Vestre Viken HF, Drammen Hospital and The Hospital of Vestfold | Drammen and Tønsberg | Buskerud and Vestfold |
| Lead Sponsor | Collaborator |
|---|---|
| Vestre Viken Hospital Trust | Kalmar County Hospital, Oslo University Hospital, The Hospital of Vestfold |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The hospital anxiety and depression scale (HADS) | Within 2 years after study inclusion | No | |
| Primary | Cardiovascular risk factors, lifestyle, and drug adherence | Within 2 years after study inclusion | No | |
| Secondary | Readmission with a coronary event, acute myocardial infarctrion and cardiovascular mortality | Within 5 years after study inclusion | No |