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Effect of Bi-ventricular Pacing on Autonomous Nervous System

2010년 10월 5일 업데이트: Far Eastern Memorial Hospital
Patients with congestive heart failure are often associated with delayed intraventricular depolarization which causing dyssynchrony and an inefficient pattern of left ventricular contraction. A number of studies have shown that bi-ventricular or left ventricular pacing improves indexes of systolic function as well as decreases sympathetic activation in patients with severe left ventricular systolic dysfunction, dilated cardiomyopathy and a major left-sided intraventricular conduction disorder such as left bundle branch block. One recent study also demonstrated that bi-ventricular pacing can shift heart rate variability (HRV) toward a more favorable profile. Baroreflex sensitivity (BRS) is a measure of the negative feedback properties that interact in modulating the dynamic heart rate and arterial pressure fluctuations. Blunted BRS is found to be associated with an increased risk for both cardiac deaths and arrhythmic events. However, the effect of bi-ventricular pacing on BRS has never been studied. In the present proposal, we plan to measure common hemodynamic parameters, BRS and HRV in a group of heart failure patients receiving open heart surgery in different pacing conditions (bi-ventricular pacing, single LV pacing, single RV pacing). The major aims are to investigate the effect of bi-ventricular pacing on BRS and to clarify the underlying mechanisms.

연구 개요

상태

알려지지 않은

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

중재적

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients with normal sinus rhythm proposed to undergo coronary artery bypass surgery.

Exclusion Criteria:

-

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Kuan-Ming Chiu, M.D., Far Eastern Memorial Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 등록 날짜

최초 제출

2005년 9월 12일

QC 기준을 충족하는 최초 제출

2005년 9월 12일

처음 게시됨 (추정)

2005년 9월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2010년 10월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2010년 10월 5일

마지막으로 확인됨

2004년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • FEMH-93014
  • Femh-93-C-014

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

Bi-ventricular pacing에 대한 임상 시험

3
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