Predicting Blood Pressure in Patients Following Defibrillation

NCT02686307 | Completed

• 1 other identifier: 00013500
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

During tachyarrhythmias, central venous pressures increases while arterial blood pressure (BP) decreases. The result is mixed messages to the central nervous system. On one hand, the unloading of the arterial baroreceptors results in reflex tachycardia and an increase in sympathetic nerve activity (SNA). On the other hand, the increase in filling pressure and thus the activation of the cardiopulmonary baroreceptors result in reflex bradycardia and sympathoinhibition. The investigators have previously shown that during supraventricular and ventricular tachycardia, arterial baroreflex gain (BRG) predominates with minimal contribution from the cardiopulmonary BRG. In addition, the investigators found that arterial BRG directly correlates with BP recovery following tachycardia termination. The roles of the arterial and cardiopulmonary BRGs during ventricular fibrillation (VF) however, remain unknown. Furthermore, the role of the arterial BRG in determining 1) BP recovery following VF induction and 2) the frequency of ventricular tachycardia (VT)/VF events in patients undergoing implantation of an implantable cardioverter/defibrillator (ICD) remain unknown. Analysis of the changes in sinus node cycle length during VF inductions in patients undergoing the implantation of a dual chamber or triple chamber ICD, provide a unique opportunity at looking at the autonomic changes that accompany VF.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Correlation of sinus node cycle length to arterial baroreflex gain

  Assessment of whether changes in sinus node cycle length during ventricular fibrillation induction correlate with arterial baroreflex gain at scheduled and unscheduled implantable cardioverter/defibrillator related hospital visits for up to 12 months

  up to 12 months

Secondary Outcomes (2)

• Blood pressure recovery post-defibrillation

  first 30 seconds after successful defibrillation

• Frequency of tachyarrhythmic events

  6 months following ICD implant

Study Arms (1)

ICD Implant

All patients receiving a dual chamber ICD

Procedure: ICD Implant

Interventions

ICD Implant PROCEDURE

Implantation of an implantable cardioverter/defibrillator

Also known as: implantable cardioverter defibrillator, Medtronic, St Jude Medical, Boston Scientific

ICD Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Indication for the implantation of an ICD with atrial lead placement
• Presence of normal sinus rhythm
• Age 18 or older

You may not qualify if:

• Moderate to severe aortic stenosis
• Embolic stroke within the last 6 months

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Interventions

Defibrillators, Implantable

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Mohomed Hamdan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: February 19, 2016
• Study Start: June 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 19, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share