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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01794832
Other study ID # SAS
Secondary ID
Status Recruiting
Phase N/A
First received February 16, 2013
Last updated April 2, 2014
Start date February 2010
Est. completion date June 2014

Study information

Verified date April 2014
Source Oslo University Hospital
Contact Amjad I Hussain, Md
Phone 0047 98043412
Email amhu@ous-hf.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Norway Oslo University hospital- Rikshospitalet Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Health related Quality and function one year after inclusion 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 one year No
Other Hospital visit and use of Health services last years 30 days No
Primary Death due cardiovascular events one year No
Secondary MACE ( Major cardiovascular events ) Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections 30 days No
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