- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00190138
Effect of Bi-ventricular Pacing on Autonomous Nervous System
연구 개요
상세 설명
Operation and lead placement:
Off-pump coronary artery bypass (OPCAB) is performed based on patient's coronary angiography. Following the completion of coronary anastomoses, epicardial pacemaker leads are implanted by simple stitches in different locations. The right atrial (RA) lead is placed on the right atrial appendage. The right ventricle (RV) lead is placed on the RV free wall near the apex. The left ventricle (LV) lead is placed on the lateral wall of LV at the border zone between diagonal and obtuse marginal branches of coronary artery. All three ground leads are placed on the rectus abdominis muscle. All these leads are pulled out of the patient percutaneously. Medtronic dual-chamber pacemaker is used for this study. The change of different pacing protocol (RV pacing, LV pacing, or biventricular pacing) is through the connection of different pacemaker leads.
Hemodynamic study:
All patients underwent OPCAB have Swan-Ganz catheter in our institute. Cardiac output measurement is obtained by thermodilution method. Hemodynamic variables (systemic blood pressure, pulmonary artery pressure, central venous pressure, pulmonary capillary wedge pressure, systemic vascular resistance, and pulmonary vascular resistance, etc) are recorded during the measurement.
ECG and blood pressure monitoring system:
ECG and radial arterial blood pressure were recorded by an analog to digital converter system (National Instrument Inc.). The ananlog signals were digitized in a rate of 500Hz and were stored in a hard disk. The data were then analyzed by a program written with MATLAB language (version 5.2, Mathwork Co.). QRS complexes were automatically classified and manually verified as normal sinus rhythm, arterial or ventricular premature beats, or noise by comparison of the adjacent QRS morphologic features. The N-N interval time series were then transferred to a personal computer and post-processed.
Baroreflex sensitivity analysis:
The analysis of BRS was conducted by both the sequence method (19, 20) and the spectral (α-index) method. Sequence method: In brief, the beat-by-beat time series of systolic arterial blood pressure and ECG R-R intervals were scanned to identify sequences of over three consecutive beats in which the systolic blood pressure (SBP) and R-R intervals of the next beat changed concomitantly in increasing or decreasing sequence. Such beat-to-beat sequences were identified as baroreflex sequences. A linear regression was applied to the individual sequence and only r2 values >0.85 were accepted. The measure of each type of the integrated spontaneous BRS was obtained by averaging all accepted slopes of the same type during a 5-minute recording. Spectral (α-index) method: The α-index (α) was obtained by means of the simultaneous spectral analysis of the R-R intervals and the SBP variabilities, with the calculation being made from the square root of the ratio between the R-R intervals and the SBP variability in low frequency (LF) band (αLF, 0.04 to 0.15 Hz). The coherence between the R-R intervals and SBP was assessed by a cross-spectral analysis. The α-index was calculated only when the magnitude of squared coherence (K2) between the RR and the SBP signals exceed 0.5 in LF band.
Heart rate variability analysis:
The missing intervals of the raw N-N data were linearly interpolated and resampled at 4 Hz by the Ron-Berger method. Each 5-minute segment of N-N intervals was taken for HRV analysis. The time domain measurements of HRV included SDNN, r-MSSD. The frequency-domain measurements of HRV included LF and HF, which were calculated by Welch's averaged periodogram of the N-N intervals.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with normal sinus rhythm proposed to undergo coronary artery bypass surgery.
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 의자: Kuan-Ming Chiu, M.D., Far Eastern Memorial Hospital
연구 기록 날짜
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. .
울혈 성 심부전증에 대한 임상 시험
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University of... 그리고 다른 협력자들아직 모집하지 않음심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
-
Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
-
University of WashingtonAmerican Heart Association완전한심부전,울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
Bi-ventricular pacing에 대한 임상 시험
-
Azienda Ospedaliera Cardinale G. Panico완전한
-
Medtronic Cardiac Rhythm and Heart Failure완전한심부전미국, 캐나다, 프랑스, 이탈리아, 영국, 벨기에, 스페인, 독일, 말레이시아, 세르비아, 남아프리카, 사우디 아라비아, 핀란드, 그리스, 호주, 네덜란드, 칠레, 헝가리, 오스트리아, 루마니아, 스위스, 슬로바키아, 노르웨이, 이스라엘, 덴마크, 인도, 슬로베니아
-
Boehringer Ingelheim완전한
-
Boehringer Ingelheim모병흑색종 | 비소세포폐암(NSCLC) | 머리와 목의 암종, 편평 세포(HNSCC)네덜란드
-
Boehringer Ingelheim완전한
-
Boehringer Ingelheim완전한