- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07641413
Lung and Heart Function Across Decades of Life in Health
Lung and Heart Function Across Decades of Life in Healthy Population
The main objective of this study is to develop baseline "normal" reference values of both lung and heart function for healthy adults within the age range relevant to the United States Veteran population who served in the Southwest Asia theater of military operations.
This study will involve performing key components of the Department of Veterans Affairs the Airborne Hazards and Open Burn Pit Center of Excellence (AHOBPCE) and a VA network of Post-Deployment Cardiopulmonary Evaluation Network (PDCEN) Core Clinical Evaluation in asymptomatic unexposed healthy controls without known lung or heart disease to serve as a "normal" control comparator group for veterans evaluated by PDCEN.
연구 개요
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mehrdad Arjomandi, MD
- 전화번호: 24393 415-221-4810
- 이메일: mehrdad.arjomandi@ucsf.edu
연구 장소
-
-
California
-
San Francisco, California, 미국, 94143
- 모병
- University of California San Francisco
-
연락하다:
- Mehrdad Arjomandi, MD
- 전화번호: 24393 415-221-4810
- 이메일: mehrdad.arjomandi@ucsf.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 24-68
- U.S. Veteran deployed between 1990 to 2021
- No respiratory complaints (defined as modified Medical Research Council score = 0)
- No use of respiratory medications
Exclusion Criteria:
- Non-English speaking
- Pregnancy
- BMI>35 Kg/m2
- Tobacco smoking within prior year
- Lifetime tobacco smoking of >5 pack-years
- Current inhaled cannabis use (any modality) >2x weekly
- Prior inhaled cannabis uses exceeding 2x weekly within the prior year
- Illicit drug use (other than cannabis)
No prior or current major organ disease, including but not limited to:
- Neuromuscular weakness
- History of malignancy (other than non-melanoma skin cancer)-- HIV/AIDS
- Autoimmune disease
- Solid-organ or hematopoietic stem cell transplant
Cardiovascular disease (other than mild HTN; < 140/90; controlled on 2 or less medications)
- Poorly-controlled HTN (SBP>140 or DBP>90 or use of more than 2 anti-hypertensive medications)
- Any history of congestive heart failure (CHF, either HFpEF or HFrEF)
- Any history of arrythmia (including atrial fibrillation)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Pulmonary Function Testing: The purpose of this test is to determine the participant's lungs' capacity.
|
2 years
|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Cardiopulmonary Exercise Testing: The purpose of this test is to determine the participant's lung and heart capacity during maximum exercise.
|
2 years
|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Echocardiogram: The purpose of this test is to determine how well the subject's heart is functioning and identify causes of cardiac-related symptoms.
|
2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
FeNO: The purpose of this test is to measure a marker of inflammation in the lungs.
|
2 years
|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Forced Oscillation Technique: The purpose of this test is to determine the resistance of the airways in the subject's lungs.
|
2 years
|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Methacholine Challenge Test: The purpose of this test is to determine how irritable the participant's airways are by administering gradually increasing doses of methacholine.
|
2 years
|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Chest CT: The purpose of this test is to examine for abnormalities and to help diagnose the cause of signs or symptoms of chest disease.
|
2 years
|
|
Normal reference values for heart and lung function within the age range relevant to the United States Veteran population.
기간: 2 years
|
Peripheral Blood Draw: The purpose of this blood draw is to determine metabolic and blood inflammatory markers.
|
2 years
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mehrdad Arjomandi, MD, University of California, San Francisco
간행물 및 유용한 링크
일반 간행물
- Zeng S, Nishihama M, Weldemichael L, Lozier H, Gold WM, Arjomandi M. Effect of twice daily inhaled albuterol on cardiopulmonary exercise outcomes, dynamic hyperinflation, and symptoms in secondhand tobacco-exposed persons with preserved spirometry and air trapping: a randomized controlled trial. BMC Pulm Med. 2024 Jan 20;24(1):44. doi: 10.1186/s12890-023-02808-7.
- Zeng S, Dunn M, Gold WM, Kizer JR, Arjomandi M. Remote exposure to secondhand tobacco smoke is associated with lower exercise capacity through effects on oxygen pulse, a proxy of cardiac stroke volume. BMJ Open Respir Res. 2022 May;9(1):e001217. doi: 10.1136/bmjresp-2022-001217.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- UCSF IRB#24-41051
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
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. .