Safety and Efficacy Iodofiltic Acid I 123 in the Treatment of Acute Coronary Syndrome (Zeus-ACS)
Open-label, Phase 2 Study of the Safety and Efficacy of B-methyl-P-(123I)- Iodophenyl-pentadecanoic Acid (Iodofiltic Acid I 123) For Identification of Ischemic Myocardium Using Single Photon Emission Computed Tomography (Spect) in Adults With Symptoms Consistent With Acute Coronary Syndrome (ACS).
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국
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Huntsville, Alabama, 미국
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Arizona
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Mesa, Arizona, 미국
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California
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Los Angeles, California, 미국
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Mission Viejo, California, 미국
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Newport Beach, California, 미국
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Roseville, California, 미국, 95661
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Connecticut
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Hartford, Connecticut, 미국
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New Haven, Connecticut, 미국
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Delaware
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Newark, Delaware, 미국
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Florida
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Jacksonville, Florida, 미국
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Illinois
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Aurora, Illinois, 미국
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Maywood, Illinois, 미국
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Kentucky
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Louisville, Kentucky, 미국, 40207
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Maine
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Auburn, Maine, 미국
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Maryland
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Bethesda, Maryland, 미국
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Michigan
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Detroit, Michigan, 미국
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Royal Oak, Michigan, 미국
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Troy, Michigan, 미국, 48085
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Minnesota
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Minneapolis, Minnesota, 미국
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Missouri
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Kansas City, Missouri, 미국, 64111
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New Hampshire
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Lebanon, New Hampshire, 미국
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Manchester, New Hampshire, 미국
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New York
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Albany, New York, 미국
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Brooklyn, New York, 미국
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Kingston, New York, 미국
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New York, New York, 미국
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Rochester, New York, 미국
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Syracuse, New York, 미국, 13210
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Ohio
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Cincinnati, Ohio, 미국
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Cleveland, Ohio, 미국
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Columbus, Ohio, 미국
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Rhode Island
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Providence, Rhode Island, 미국
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Texas
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Houston, Texas, 미국
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Virginia
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Richmond, Virginia, 미국
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Wisconsin
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Madison, Wisconsin, 미국
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British Columbia
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North Vancouver, British Columbia, 캐나다
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Ontario
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Scarborough, Ontario, 캐나다
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Provide written informed consent and are willing to comply with protocol requirements
- Are 40 years of age or older.
- Are being evaluated for possible ACS.
- If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.
Exclusion Criteria:
- <40 years of age.
- Females who are pregnant or lactating.
- History of left ventricular ejection fraction (LVEF)=40%.
- History of MI.
- Acute ST segment elevation on ECG.
- Left bundle branch block on ECG.
- Known history of significant allergy to x-ray contrast media or iodine/iodides.
- Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
- Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
- Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
- Serum creatinine level >2.0 mg per dL.
- Received investigational compound and/or medical device within 30 days of admission into this study.
- Q-wave abnormalities consistent with previous MI
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Iodofiltic Acid I 123
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 1)
기간: Day 30
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Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. |
Day 30
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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 2)
기간: Day 30
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Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. |
Day 30
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Sensitivity, Specificity of Detecting Myocardial Ischemia (Reader 3)
기간: Day 30
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Enrolled subjects were imaged (10 minutes post-injection) using iodofiltic acid I 123 SPECT and the resulting data were reviewed in blinded reads by readers independent of the study centers and the Sponsor. The results obtained in these blinded reads were compared with the final diagnosis for each subject with regard to myocardial ischemia or ACS, determined by the Final Diagnosis Clinical Endpoints Committee (FDCEC). Sensitivity = % (n/N): N = number of subjects positive for ischemia per the FDCEC; n = subset of N positive for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. Specificity = % (n/N): N = number of subjects negative for ischemia per the FDCEC; n = subset of N negative for ischemia per the blinded Majority Read (two of three readers) of iodofiltic acid I 123 readers. |
Day 30
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공동 작업자 및 조사자
수사관
- 연구 책임자: Norman LaFrance, MD, Molecular Insight Pharmaceuticals, Inc.
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .
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