Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The NOR-COR Study for Coronary Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02309255
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : June 15, 2015
Sponsor:
Collaborators:
The Hospital of Vestfold
Oslo University Hospital
Kalmar County Hospital
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

Brief Summary:

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.


Condition or disease Intervention/treatment
Secondary Coronary Prevention Other: no intervention

Layout table for study information
Study Type : Observational
Actual Enrollment : 975 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Study Start Date : February 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Group/Cohort Intervention/treatment
coronary heart disease patients Other: no intervention



Primary Outcome Measures :
  1. Cardiovascular risk factors, lifestyle, and drug adherence [ Time Frame: Within 2 years after study inclusion ]

Secondary Outcome Measures :
  1. Readmission with a coronary event, acute myocardial infarctrion and cardiovascular mortality [ Time Frame: Within 5 years after study inclusion ]

Other Outcome Measures:
  1. The hospital anxiety and depression scale (HADS) [ Time Frame: Within 2 years after study inclusion ]

Biospecimen Retention:   Samples With DNA
Salvia for genetic analyses


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
1365 CHD patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309255


Locations
Layout table for location information
Norway
Vestre Viken HF, Drammen Hospital and The Hospital of Vestfold
Drammen and Tønsberg, Buskerud and Vestfold, Norway, N-3004
Sponsors and Collaborators
Vestre Viken Hospital Trust
The Hospital of Vestfold
Oslo University Hospital
Kalmar County Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT02309255     History of Changes
Other Study ID Numbers: NOR-COR REK ID 2013/1885
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015
Keywords provided by Vestre Viken Hospital Trust:
Secondary coronary prevention
Psychosocial factors
Cardiac rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes