- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07819344
Molecular Imaging to Identify Predictors of Aortic Valve Disease Activity
Molecular Imaging and Deep Phenotyping to Identify Predictors of AS Disease Activity and Progression
연구 개요
상세 설명
Structural imaging modalities, such as echocardiography (echo) and computed tomography (CT), measure the structural consequences of aortic valvular calcification and have proven invaluable for grading AS severity. However, these techniques cannot capture the dynamic microcalcification processes that drive the underlying disease and have proven insufficient for predicting AS progression. In contrast, molecular imaging with 18F-NaF positron emission tomography/computed tomography (18F-NaF PET/CT) is the gold-standard method for noninvasively measuring the central pathophysiological process driving the progression of AS. This imaging approach uses 18F-sodium fluoride, a tracer that binds preferentially to hydroxyapatite in regions of developing microcalcification. This enables quantification of microcalcification activity (which precedes visible macrocalcification) and provides insights into the underlying disease activity that drives AS progression. Notably, optimized protocols for 18F-NaF PET/CT yield a reproducible biomarker to track disease activity and predict progression. Furthermore, recent advances in PET technology (such as total-body PET scanners) have improved sensitivity by 10- to 40-fold, further enhancing the quantification of the microcalcification rate underlying AS progression.
Overall, the assessment of microcalcification activity shifts the focus from static anatomical assessments to measurement of the dynamic pathological process driving AS progression. However, while 18F-NaF PET/CT is unsuitable for routine clinical use (because it is costly and currently limited to research applications), it can be effectively leveraged to train predictive models and deploy them as clinical calculators to estimate the rate of microcalcification from readily available biomarker data. The resulting clinical models and calculators could greatly enhance clinical care by identifying patients at risk of rapid progression, refining risk stratification and prognostic accuracy, and opening avenues for personalized monitoring and treatment in calcific AS.
The overarching goal of this Clinical Imaging Study is to develop novel predictive models and clinical calculators that capture AS microcalcification activity and forecast the risk of progressive aortic valve stenosis among participants with mild-to-moderate AS. The investigators will achieve this by performing advanced multimodality imaging, including 18F-NaF PET/CT, to quantify microcalcification activity in deeply phenotyped patients using clinical, imaging, and blood plasma biomarkers. Computational approaches, including AI tools, will identify optimal combinations of imaging and non-imaging predictors of microcalcification activity. The investigators will then develop accessible clinical calculators and test the hypothesis that these models and calculators enhance identification of rapid progressors through cross-validation and external validation in the Population Project cohort (which undergoes identical biomarker phenotyping).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ahmed Tawakol A Director, MD
- 전화번호: 3699 6177262000
- 이메일: atawakol@mgh.harvard.edu
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Males and females
- aged 18 years or older
- mild to moderate calcific Aortic Stenosis (as defined by standard echocardiographic criteria)
Exclusion Criteria:
- Bicuspid Aortic Stenosis
- pregnancy
- cognitive disabilities that impair the ability to comply with instructions or provide informed consent
- any other medical condition that may undermine participation
- weight >300 lbs
- severe claustrophobia
- Pregnancy
- subjects who have had significant radiation exposure as part of research (>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12 months
- Individuals with renal dysfunction (eGFR<55) or a history of allergic reaction to iodinated contrast will not receive the iodinated contrast.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Individuals with mild or moderate aortic stenosis
Mild or moderate aortic stenosis noted on imaging and not expected to undergo treatment of the aortic valve over the next year.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
rate of AS progression
기간: One year
|
change of echo- and CT-derived AS measures
|
One year
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026p001100
- 26SFRNPVHD1623048 (기타 보조금/기금 번호: American Heart Association)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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