Severe Aortic Stenosis in Patients Referred for Valve Surgery (SAS)

This study is currently recruiting participants.
Verified April 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Amjad Iqbal Hussain, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01794832
First received: February 16, 2013
Last updated: April 2, 2014
Last verified: April 2014

February 16, 2013
April 2, 2014
February 2010
April 2014   (final data collection date for primary outcome measure)
Death due cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01794832 on ClinicalTrials.gov Archive Site
MACE ( Major cardiovascular events ) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections
Cerebrovascular events du to surgical interventions [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change in Health related Quality and function one year after inclusion [ Time Frame: one year ] [ Designated as safety issue: No ]
    Patients in the study perform Short Form-36, EuroQual-5D at inclusion and one year after. We want to compare the result of their scoring to obtain the gain in HRQoL of the intervention
  • Hospital visit and use of Health services last years [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Kidney failure due surgical intervention [ Time Frame: 30 days ] [ Designated as safety issue: No ]
 
Severe Aortic Stenosis in Patients Referred for Valve Surgery
A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.

Our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to traditional parameters will improve pre-operative risk assessment in patients with AS and better guide patients and doctors in decision whether to operate or not.

Patients referred for surgery are included thorough reading referral letter. Data collected in the study wil be compared with data from Medical records and clinical examination.

Data entered will be controlled by two investigators.

Data wil be compared to national norms and from result of other studies.

Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
1 Year
Retention:   Samples With DNA
Description:

Serum, myocardial biopsi

Non-Probability Sample

Inclusion: Patients above 18 years with symptomatic AS referred to preoperative examination will be included. Patients will undergo standard investigations with regard to assessment of the clinical indication for operation

  • Aortic Stenosis
  • Valvular Heart Disease
  • Symptomatic Aortic Stenosis
Not Provided
Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
June 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients above 18 years with symptomatic AS referred to preoperative examination.

Exclusion Criteria:

  • Exclusion: Patients who do not want to participate. Patients not able to speak and read Norwegian.
Both
18 Years and older
No
Contact: Amjad I Hussain, Md 0047 98043412 amhu@ous-hf.no
Norway
 
NCT01794832
SAS
No
Amjad Iqbal Hussain, Oslo University Hospital
Oslo University Hospital
Not Provided
Study Director: Kjell I Pettersen, MD University of Oslo
Principal Investigator: Amjad I Hussain, MD Oslo University Hosptial
Study Chair: Lars Gullestad, Professor Oslo University Hospital
Oslo University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP