Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery?
This study is ongoing, but not recruiting participants.
Sponsor:
Medical University of Graz
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00942786
First received: July 18, 2009
Last updated: October 4, 2012
Last verified: October 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 18, 2009 | ||||
| Last Updated Date | October 4, 2012 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Major adverse cardiac event [ Time Frame: in-hospital and during 3 years follow-up ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Major adverse cardiac event [ Time Frame: in-hospital and during 1 year follow-up ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00942786 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Natriuretic Peptides - Predictors of In-hospital and Long-term Major Adverse Cardiac Events After Emergency Surgery? | ||||
| Official Title ICMJE | Prospective Study to Evaluate the Predictive Value of Brain Natriuretic Peptides for Adverse Long-term Cardiac Outcome | ||||
| Brief Summary | The investigators hypothesize that the level of perioperative natriuretic peptides is associated with in-hospital and long term major adverse cardiac events. |
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| Detailed Description | The purpose of the study is to measure levels of brain natriuretic peptides before and after urgent non-cardiac surgery and to evaluate their predictive value for adverse long-term outcome. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: one vial of serum per patient is retained |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Consecutive patients undergoing emergency non-cardiac surgery |
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| Condition ICMJE | 3 Years Cardiac Morbidity and Mortality | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | No treatment
Consecutive patients undergoing emergency surgery |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 302 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00942786 | ||||
| Other Study ID Numbers ICMJE | 19-077 ex 07/08 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Medical University of Graz | ||||
| Study Sponsor ICMJE | Medical University of Graz | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Graz | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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