심부전 및 대동맥 협착증 전사체 (RNA-HF-AS)
심부전 및 대동맥 협착증의 전사 변화에 관한 연구
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.
연구 개요
상세 설명
The investigators will collect plasma and cardiac tissue specimens from consenting subjects. The investigators will evaluate the expression of mRNAs, miRNAs and lncRNAs in patients affected by both end-stage and not end-stage HF as well as in patients affected by aortic stenosis and undergoing valve replacement and requiring cardiac myectomy. The tissue dysregulated RNAs will be next measured in plasma samples in order to clarify their potential as biomarkers.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Fabio Martelli, Dr
- 전화번호: +39 02 26437762
- 이메일: fabio.martelli@grupposandonato.it
연구 장소
-
-
-
Milan, 이탈리아, 20132
- 모병
- Ospedale San Raffaele
-
연락하다:
- Michele De Bonis, MD, PhD
- 이메일: debonis.michele@hsr.it
-
수석 연구원:
- MICHELE DE BONIS, MD FESC FAHA
-
-
Milan
-
San Donato Milanese, Milan, 이탈리아, 20097
- 모병
- Irccs Policlinico San Donato
-
연락하다:
- FABIO MARTELLI, PhD
- 전화번호: 0252774683
- 이메일: fabio.martelli@grupposandonato.it
-
부수사관:
- SIMONA GRECO, PhD
-
부수사관:
- LORENZO MENICANTI, MD
-
부수사관:
- SERENELLA CASTELVECCHIO, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Cardiac surgery patients
설명
Inclusion Criteria:
-
Non end-stage heart failure
- left ventricle restoration surgery (SVR)
- End Systolic Volume Index (ESVI) >35 ml/m2
- Ejection Fraction (EF)<40%
- previous transmural anterior myocardial infarction (MI)
- age: 40-75
-
End-stage heart failure
- left ventricle assisted device (LVAD) surgery
- age: 40-75
- Ejection Fraction (EF) <25%
- End Systolic Volume Index (ESVI)≥60 ml/m2
-
Aortic Stenosis
- aortic valve replacement
- intracardial pressure difference >40 mmHg
- septal diameter ≥1.3 cm
Exclusion Criteria:
-
Non end-stage heart failure
- End Systolic Volume Index (ESVI)<35 ml/m2
- Ejection Fraction (EF)>40%
- Time from MI unknown
- Pregnancy
- Other genetic diseases
- Neoplasms
- Collagenopathies
- Chemo/radiotherapy
- Prolonged use of corticosteroids
- Infections
- Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
-
End-stage heart failure
- EF>25%
- Time from MI unknown
- Pregnancy
- Other genetic diseases
- Neoplasms
- Collagenopathies
- Chemo/radiotherapy
- Prolonged use of corticosteroids
- Infections
- Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
-
Aortic Stenosis
- coronaropathies
- Pregnancy
- Other genetic diseases
- Neoplasms
- Collagenopathies
- Chemo/radiotherapy
- Prolonged use of corticosteroids
- Infections
- Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: RETROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Non end-stage heart failure
Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction |
|
|
End-stage heart failure
Measurement of RNAs in end-stage heart failure patients undergoing to left ventricular assisted device (LVAD) |
|
|
Aortic Stenosis
Measurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy |
|
|
Controls
Measurement of RNAs in individuals not affected by cardiovascular diseases |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiac tissutal mRNAs signatures
기간: from Year 1 to Year 3
|
The mRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls |
from Year 1 to Year 3
|
|
Cardiac tissutal miRNAs signatures
기간: from Year 1 to Year 3
|
The miRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls |
from Year 1 to Year 3
|
|
Cardiac tissutal lncRNAs signatures
기간: from Year 1 to Year 3
|
The lncRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls |
from Year 1 to Year 3
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas
기간: from Year 3 to Year 5
|
The mRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls |
from Year 3 to Year 5
|
|
Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas
기간: from Year 3 to Year 5
|
The miRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls |
from Year 3 to Year 5
|
|
Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas
기간: from Year 3 to Year 5
|
The lncRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls |
from Year 3 to Year 5
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Fabio Martelli, Dr, IRCCS Policlinico S. Donato
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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 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. .