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NCT Number: NCT02309255

The NOR-COR Study for Coronary Prevention

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vestre Viken HF, Drammen Hospital and The Hospital of Vestfold

Drammen and Tønsberg, Buskerud and Vestfold, N-3004, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Cardiovascular risk factors, lifestyle, and drug adherence

    Time frame: Within 2 years after study inclusion

Secondary outcomes

  1. Readmission with a coronary event, acute myocardial infarctrion and cardiovascular mortality

    Time frame: Within 5 years after study inclusion

Other outcomes

  1. The hospital anxiety and depression scale (HADS)

    Time frame: Within 2 years after study inclusion

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Kalmar County Hospital
  • Oslo University Hospital
  • The Hospital of Vestfold

Registry information

Official study title

The NOR-COR (NORwegian CORonary) Study: Identification of CHD Patients With Poor Adherence to Secondary Prevention and Their Perceived Needs for Follow-up

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2014
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.