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Atrial FibrillationNCT00321945

A Retrospective Analysis of the Use of ACE-inhibitors and Angiotensin Receptor Blockers

An observational study of Atrial Fibrillation and Atrial Flutter, run by Emory University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is well known that atrial fibrillation (AF) and atrial flutter occur frequently after most types of cardiac surgeries.(1-4) Postoperative AF is associated with significant morbidity, longer hospital stay, and higher related costs. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atrial Fibrillation, Atrial Flutter
What is being tested?
ACE-Inhibitors and Angiotensin Receptor Blockers
Type of treatment
Surgery or procedure
How many people
546 participants
Where
3 sitesUnited States
Study dates
Dec 2005to Oct 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All patients, 18 years or older up to and including 65 years of age, who underwent elective cardiac surgery in the Emory University Hospital, Crawford Long Hospital, or the VA Medical Center between 2000-2005.

Who may be able to join

  • All patients who underwent elective cardiac surgery in the Emory University Hospital, Crawford Long Hospital, or the VA Medical Center between 2000-2005.

Who cannot join

  • Emergent operations.
  • The presence of AF or atrial flutter at the time of surgery.
  • Patients without adequate documentation of atrial rhythm following surgery.
  • NYHA class IV heart failure at the time of surgery.
  • Hyperthyroidism
  • Implanted devices for designed for active management of atrial arrhythmias by pacing or defibrillation
Show all 9Show fewer
  • Known illicit drug use
  • Known ethanol abuse
  • Electrophysiological ablation for atrial tachycardia within 6 months of the operation.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Crawford Long Hospital

    Atlanta, Georgia, 30365

  • Veterans Administration Medical Center

    Decatur, Georgia, 30033

Other trials in United States

About this study

Official title: A Retrospective Analysis of the Use of ACE-inhibitors and Angiotensin Receptor Blockers on Post-Operative Atrial Fibrillation

It is well known that atrial fibrillation (AF) and atrial flutter 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

Read the 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 atrial flutter. 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:

  1. Emergent operations.
  2. The presence of AF or atrial flutter at the time of surgery.
  3. Patients without adequate documentation of atrial rhythm following surgery.
  4. New York Heart Association (NYHA) class IV heart failure at the time of surgery.
  5. Hyperthyroidism
  6. Implanted devices for designed for active management of atrial arrhythmias by pacing or defibrillation
  7. Known illicit drug use
  8. Known ethanol abuse
  9. Electrophysiological ablation for atrial tachycardia within 6 months of the operation.

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 atrial flutter 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 atrial flutter, previous cardiovascular events, 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 atrial flutter. The null hypothesis is that there is no association between the preoperative use of ACE Inhibitors and ARBs and postoperative AF and atrial flutter. Within the cohort, those patients with AF or atrial flutter 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 ± standard deviation 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.

Being tested
ACE-Inhibitors and Angiotensin Receptor Blockers
Keywords
Atrial Fibrillation, Atrial Flutter, Angiotensin Converting Enzyme Inhibitor, Angiotensin Receptor Blocker
Medical subject headings
Atrial Fibrillation, Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACE-Inhibitors and Angiotensin Receptor BlockersProcedure or surgery

    Retrospective study - no intervention as part of study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the relationship of pre-operative ACE inhibitor or ARB use to the incidence of post-operative atrial arrhythmias.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321945
Sponsor's protocol ID
IRB00002174
Status last verified
Sep 2013
First submitted
1 May 2006
Last updated
27 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Flutter, run by Emory University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the relationship of pre-operative ACE inhibitor or ARB use to the incidence of post-operative atrial arrhythmias. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2013.

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