Trial record 17 of 88 for:    Open Studies | "Pulmonary Embolism"

Surfactant Associated Protein - A Novel Marker for the Diagnosis of Pulmonary Embolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01353365
First received: May 12, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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.


Condition
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surfactant Associated Protein - A Novel Marker for the Diagnosis of Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 150
Study Start Date: June 2011
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with PE at ER and Internal B department at the Rambam Medical Center

Criteria

Inclusion Criteria:

  • Patients with proven PE by CT- angiography or by V-Q scans (only high likelihood scans will be regarded as proven PE).

Exclusion Criteria:

  • Under 18 years old.
  • Unable to sign informed consent
  • Other known pulmonary disease such as IPF, ARDS
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353365

Contacts
Contact: Amir solomonica, Dr. a_solomonica@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Berger Gideon, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Dr. Gideon Berger, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01353365     History of Changes
Other Study ID Numbers: 0462-09/CTIL
Study First Received: May 12, 2011
Last Updated: May 12, 2011
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014