A Retrospective Analysis of the Use of ACE-Inhibitors and Angiotensin Receptor Blockers
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 1, 2006 | ||||
| Last Updated Date | April 10, 2007 | ||||
| Start Date ICMJE | December 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00321945 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Retrospective Analysis of the Use of ACE-Inhibitors and Angiotensin Receptor Blockers | ||||
| Official Title ICMJE | A Retrospective Analysis of the Use of ACE-Inhibitors and Angiotensin Receptor Blockers on Post-Operative Atrial Fibrillation | ||||
| Brief Summary | It is well known that atrial fibrillation (AF) and atrial flutter (Aflut) occur frequently after most types of cardiac surgeries.(1-4) Postoperative AF is associated with significant morbidity, longer hospital stay, and higher related costs. Currently, it is common procedure to premedicate patients with antiarrhythmic drugs for elective cardiac surgeries. Treatments such as beta blockers, Amiodarone, and electrical pacing are used to help prevent the morbidity associated with pot-operative AF.(5) Renin-angiotensin system (RAS) activation may contribute to AF. Several clinical trials have suggested that inhibitors of this system may reduce the incidence of AF.(6-12) Patients with AF are known to have increased levels of angiotensin converting enzyme (ACE) and some types of angiotensin receptors.(13-15) Data from animal studies performed by our group suggest that cardiac ACE overexpression may lead to arrhythmic ion channel changes.(16;17) Although not studied in this group yet, it would be reasonable to conclude that the use of ACE inhibitors and angiotensin receptor blockers (ARBs) would decrease the incidence of AF in post-operative patients, too |
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| Detailed Description | 2.0 Objectives Based on the discussion above, we hypothesize that patients premedicated on ACE Inhibitors and ARBs will have a decreased incidence of post-operative AF or Aflut. This study will be a retrospective cohort analysis of all patients that underwent elective cardiac surgeries between 2000-2005 at Emory University Hospital, Crawford Long Hospital, or the Atlanta Veterans Affairs Medical Center to evaluate the relationship of pre-operative ACE inhibitor or ARB use to the incidence of post-operative atrial arrhythmias.. This study is undertaken in preparation for a funding proposal for a prospective trial. 3.0 Patient Selection 3.1 Eligibility criteria: 1. All patients that patients who underwent elective cardiac surgery in the Emory University Hospital, Crawford Long Hospital, or the VA Medical Center between 2000-2005. 3.2 Ineligibility criteria:
4.0 Registration and randomization: none 5.0 Therapy: none 6.0 Pathology: none 7.0 Patient assessment: none 8.0 Data collection: Data will be collected from review of the patient’s hospital charts, from telemetry recordings, and ECGs to document the presence or absence of AF or Aflut during the hospital admission for cardiac surgery. The presence or absence of atrial fibrillation will be diagnosed on the basis of an electrocardiographic recording and confirmed by a cardiologist. Demographic data collected will include: age, race, sex, body mass index, blood pressure, NYHA classification, Killip classification, and the history of previous myocardial infarction, hypertension, diabetes, smoking, alcohol use, antiarrhythmic drug use, presence and type of pacemaker if any, history of AF or Aflut, previous CVs, type of operation, and length of operation. Patients enrolled in this study will be given unique study numbers. No follow up data will be required from patients. 9.0 Statistical considerations: This study design is a retrospective chart review of a cohort of patients undergoing cardiac surgery to determine if there is an association between pre-operative ARB or ACE inhibitor use and the incidence of post-operative atrial fibrillation or Aflut. The null hypothesis is that there is no association between the preoperative use of ACE Inhibitors and ARBs and postoperative AF and Aflut. Within the cohort, those patients with AF or Aflut will be compared to those without these atrial arrhythmias in the post-operative period. Baseline data for the two groups will be expressed as mean ± SD for continuous variables, and frequencies for categorical variables. Differences in baseline characteristics between the groups will be examined by use of Fisher exact and Mann-Whitney tests for categorical and continuous variables, respectively. Quantification of any association between pre-operative ACE Inhibitors and ARBs and the presence of atrial fibrillation will modeled by logistical regression analysis after adjusting for other variables that may affect arrhythmia frequency. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: ACE-Inhibitors and Angiotensin Receptor Blockers | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 600 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00321945 | ||||
| Other Study ID Numbers ICMJE | 1307-2005 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Emory University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Emory University | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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