Surfactant Associated Protein - A Novel Marker for the Diagnosis of Pulmonary Embolism
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 12, 2011 | ||||
| Last Updated Date | May 12, 2011 | ||||
| Start Date ICMJE | June 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| 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 | Surfactant Associated Protein - A Novel Marker for the Diagnosis of Pulmonary Embolism | ||||
| Official Title ICMJE | Surfactant Associated Protein - A Novel Marker for the Diagnosis of Pulmonary Embolism | ||||
| Brief Summary | Acute dyspnea and chest discomfort are common complaints. Distinguishing between the entities that may present with such symptoms can be difficult. This project aims to study - venous thromboembolism (VTE) - a difficult diagnosis that can easily be missed yet its treatment is highly effective. VTE represents a spectrum of disease ranging from deep vein thrombosis to pulmonary embolism (PE). Early diagnosis of PE is usually based on suspicion raised by clinical symptoms combined with a medical history of obvious predisposing factors. However, in around 30% of cases PE occurs in the absence of any predisposing factors. Individual clinical signs and symptoms are neither sensitive nor specific. PE is generally associated with hypoxaemia, but up to 20% of patients with PE have a normal arterial oxygen pressure .Classic ECG changes are generally associated with the more severe forms of PE. Bio-markers such as Plasma D-dimer (DD) have been investigated extensively in recent years. It has been shown that a normal DD level renders acute PE or DVT unlikely; on the other hand DD is not useful for confirming VTE. CT angiography(CTA) has become the method of choice for imaging the pulmonary vasculature for suspected PE. Yet as in DD the pre-test probability of PE based on the clinician's abilities highly affects the results of the CT. While VTE is a fairly common and sometimes lethal condition its diagnosis is difficult and based more on clinical hunches than on highly sensitive and specific diagnostic tools. It's quite evident that finding a novel, sensitive and even more importantly specific biomarker for PE would change the current approach and work-up needed for reaching a diagnosis. We propose using serum levels of surfactant associated protein (SAP) as such a bio-marker. Surfactant is a unique phospholipoprotein secreted solely by type II alveolar cells in the lungs. About 90% of the surfactant structure is composed of phospholipids and the remaining 10% is composed of specific proteins. Working hypothesis and aims: PE causes ischemic damage to lung tissue. Such damage will ultimately lead to a rise of serum SPA. The primary objective of this project is to ascertain the fact that indeed there is a rise of serum SPA among patients diagnosed with PE, what is the time-concentration profile of such rise and is the rise correlated to the size of the embolus. Methods: The study will be designed as a prospective study consisting of several steps. The measurement of serum SPA will be done by commercially available ELISA kits. All patients will be enrolled by researchers from both the ER and internal B ward at the Rambam Medical Center. Probable implications to Medicine: If indeed SPA levels will be proven to be a novel bio-marker for PE this could ultimately lead to a totally different approach in the classification and treatment of patients presenting with signs that may be associated with PE. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients diagnosed with PE at ER and Internal B department at the Rambam Medical Center |
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| Condition ICMJE | Pulmonary Embolism | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01353365 | ||||
| Other Study ID Numbers ICMJE | 0462-09/CTIL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Gideon Berger, Rambam Health Care Campus | ||||
| Study Sponsor ICMJE | Rambam Health Care Campus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rambam Health Care Campus | ||||
| Verification Date | April 2011 | ||||
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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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