We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Amjad Iqbal Hussain, Oslo University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794832
First Posted: February 20, 2013
Last Update Posted: April 3, 2014
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.
Information provided by (Responsible Party):
Amjad Iqbal Hussain, Oslo University Hospital
  Purpose
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.

Condition
Aortic Stenosis Valvular Heart Disease Symptomatic Aortic Stenosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Prospective Longitudinal Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.

Resource links provided by NLM:


Further study details as provided by Amjad Iqbal Hussain, Oslo University Hospital:

Primary Outcome Measures:
  • Death due cardiovascular events [ Time Frame: one year ]

Secondary Outcome Measures:
  • MACE ( Major cardiovascular events ) [ Time Frame: 30 days ]
    Cerebral complications (stroke/bleeding), bleeding, renal failure, arrythmias, needs for pacemaker, prolong ICU stay, wound infections


Other Outcome Measures:
  • Change in Health related Quality and function one year after inclusion [ Time Frame: one year ]
    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 ]

Biospecimen Retention:   Samples With DNA
Serum, myocardial biopsi

Estimated Enrollment: 500
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elderly with severe aortic stenosis
Patients with severe symptomatic aortic stenosis referred for consideration of surgical aortic valve replacement

Detailed 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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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.
  Contacts and Locations
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): NCT01794832


Contacts
Contact: Amjad I Hussain, Md 0047 98043412 amhu@ous-hf.no

Locations
Norway
Oslo University hospital- Rikshospitalet Recruiting
Oslo, Norway
Contact: Lars Gullestad, professor       lars.gullestad@medisin.uio.no   
Principal Investigator: Amjad Iqbal Hussain         
Principal Investigator: Andreas Auensen, Md         
Sponsors and Collaborators
Oslo University Hospital
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amjad Iqbal Hussain, Md, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01794832     History of Changes
Other Study ID Numbers: SAS
First Submitted: February 16, 2013
First Posted: February 20, 2013
Last Update Posted: April 3, 2014
Last Verified: April 2014

Keywords provided by Amjad Iqbal Hussain, Oslo University Hospital:
HRQoL
Aortic stenosis
Aortic valve surgery

Additional relevant MeSH terms:
Heart Diseases
Constriction, Pathologic
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Ventricular Outflow Obstruction