NCT01551927

Brief Summary

Aim: To investigate and compare women's and men's expectations before investigation and treatment of suspected coronary artery disease and to examine how these expectations are met. Do women and men, of different ages, have the same expectations for the evaluation and treatment of stable coronary artery disease and are their expectations met in a equal degree? Are there differences in expectations and the fulfilment of these according to age and other clinical history variables? Do the findings in the specially developed questionnaire designed to gather patients' expectations to the outcome on quality of life and degree of angina pectoris relate to their appearance in the designated forms? Is there a relationship between NTproBNP - levels, as a measure of cardiac workload, and expectations and the fulfilment of these as well as the quality of life and degree of angina pectoris? Method: Patients will be asked to participate in the study, in the context of medical consultation before coronary angiography by a physician and / or a study nurse. This occurs during an outpatient visit at the cardiac clinic at the respective centre. Included are all patients planned for elective coronary angiography before possible revascularization during a eight month period regardless of diagnosis. Including are four hospitals in the region of Västra Götaland.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
754

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

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

March 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

March 9, 2012

Last Update Submit

February 17, 2014

Conditions

Keywords

expectations

Eligibility Criteria

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

Patients planned for elective coronary angiography

You may qualify if:

  • \<18 Years of Age.

You may not qualify if:

  • Inability to communicate verbally or in writing.
  • Unwillingness to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Vastra Gotalands Regionen, 41345, Sweden

Location

Related Publications (10)

  • Stables RH. Design of the 'Stent or Surgery' trial (SoS): a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease. Semin Interv Cardiol. 1999 Dec;4(4):201-7. doi: 10.1006/siic.1999.0101.

    PMID: 10738353BACKGROUND
  • Waters DD. Medical therapy versus revascularization: the atorvastatin versus revascularization treatment AVERT trial. Can J Cardiol. 2000 Jan;16 Suppl A:11A-3A.

    PMID: 10653925BACKGROUND
  • Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

    PMID: 17387127BACKGROUND
  • Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.

    PMID: 15007010BACKGROUND
  • Odell A, Grip L, Hallberg LR. Restenosis after percutaneous coronary intervention (PCI): experiences from the patients' perspective. Eur J Cardiovasc Nurs. 2006 Jun;5(2):150-7. doi: 10.1016/j.ejcnurse.2005.10.004. Epub 2005 Nov 16.

    PMID: 16297663BACKGROUND
  • Årsrapport Swedeheart 2009 s 84 fig 76 http://www.ucr.uu.se/swedeheart/

    BACKGROUND
  • Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995 Feb;25(2):333-41. doi: 10.1016/0735-1097(94)00397-9.

    PMID: 7829785BACKGROUND
  • Sullivan M, Karlsson J. The Swedish SF-36 Health Survey III. Evaluation of criterion-based validity: results from normative population. J Clin Epidemiol. 1998 Nov;51(11):1105-13. doi: 10.1016/s0895-4356(98)00102-4.

    PMID: 9817128BACKGROUND
  • Taft C, Karlsson J, Sullivan M. Performance of the Swedish SF-36 version 2.0. Qual Life Res. 2004 Feb;13(1):251-6. doi: 10.1023/B:QURE.0000015290.76254.a5.

    PMID: 15058805BACKGROUND
  • Eilertsson Göran. Enkäten i praktiken. 1996,2005 www.studenlitteratur.se Studentlitteratur AB Lund 2009 sid 99-104, 151-153

    BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples NtProBNP

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Lars Grip, Prof

    Sahlgrenska University Hospital Per Dubbscatan 15 41345 Göteborg Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 13, 2012

Study Start

March 1, 2011

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations