NCT02309255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

November 24, 2014

Last Update Submit

June 12, 2015

Conditions

Keywords

Secondary coronary preventionPsychosocial factorsCardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular risk factors, lifestyle, and drug adherence

    Within 2 years after study inclusion

Secondary Outcomes (1)

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

    Within 5 years after study inclusion

Other Outcomes (1)

  • The hospital anxiety and depression scale (HADS)

    Within 2 years after study inclusion

Study Arms (1)

coronary heart disease patients

Other: no intervention

Interventions

coronary heart disease patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1365 CHD patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken HF, Drammen Hospital and The Hospital of Vestfold

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

Location

Related Publications (5)

  • Sverre E, Peersen K, Perk J, Husebye E, Gullestad L, Dammen T, Otterstad JE, Munkhaugen J. Challenges in coronary heart disease prevention - experiences from a long-term follow-up study in Norway. Scand Cardiovasc J. 2021 Apr;55(2):73-81. doi: 10.1080/14017431.2020.1852308. Epub 2020 Dec 4.

  • Sverre E, Peersen K, Weedon-Fekjaer H, Perk J, Gjertsen E, Husebye E, Gullestad L, Dammen T, Otterstad JE, Munkhaugen J. Preventable clinical and psychosocial factors predicted two out of three recurrent cardiovascular events in a coronary population. BMC Cardiovasc Disord. 2020 Feb 5;20(1):61. doi: 10.1186/s12872-020-01368-6.

  • Munkhaugen J, Hjelmesaeth J, Otterstad JE, Helseth R, Sollid ST, Gjertsen E, Gullestad L, Perk J, Moum T, Husebye E, Dammen T. Managing patients with prediabetes and type 2 diabetes after coronary events: individual tailoring needed - a cross-sectional study. BMC Cardiovasc Disord. 2018 Aug 3;18(1):160. doi: 10.1186/s12872-018-0896-z.

  • Sverre E, Otterstad JE, Gjertsen E, Gullestad L, Husebye E, Dammen T, Moum T, Munkhaugen J. Medical and sociodemographic factors predict persistent smoking after coronary events. BMC Cardiovasc Disord. 2017 Sep 6;17(1):241. doi: 10.1186/s12872-017-0676-1.

  • Sverre E, Peersen K, Husebye E, Gjertsen E, Gullestad L, Moum T, Otterstad JE, Dammen T, Munkhaugen J. Unfavourable risk factor control after coronary events in routine clinical practice. BMC Cardiovasc Disord. 2017 Jan 21;17(1):40. doi: 10.1186/s12872-016-0387-z.

Biospecimen

Retention: SAMPLES WITH DNA

Salvia for genetic analyses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2014

First Posted

December 5, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations