- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01353365
Surfactant Associated Protein - A Novel Marker for the Diagnosis of Pulmonary Embolism
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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
수사관
- 수석 연구원: Berger Gideon, MD, Rambam Health Care Campus
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
폐 색전증에 대한 임상 시험
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University of Colorado, Denver모병단심실 | 폐 혈관 저항 이상 | 대사체학 | 우수한 Cavo-Pulmonary 문합 | 엔도텔린미국