Text Size

Aortic Stenosis in Elderly (ASE)

This study is currently recruiting participants.
Verified February 2013 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: February 19, 2013
Last verified: February 2013
History of Changes
  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
Severe Aortic Stenosis
Asymptomatic Severe Aortic Stenosis'
Symptomatic Severe 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 Study of Severe Aortic Stenosis in Elderly and Outcome of Aortic Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Death due cardiovascular events [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebrovascular events du to surgical interventions [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Kidney failure due surgical intervention [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 500
Study Start Date: February 2010
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794832

Contacts
Contact: Amjad Iqbal 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            
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

No publications provided

Responsible Party: Amjad Iqbal Hussain, Md, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01794832     History of Changes
Other Study ID Numbers: ASE
Study First Received: February 16, 2013
Last Updated: February 19, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on May 21, 2013