The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics

August 17, 2023 updated by: University of Nebraska
The study will examine role of transvenous pacing on coronary microcirculation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

To study the role of transvenous pacing on the coronary microcirculation. This will be accomplished by gathering data from invasive Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) with and without ventricular pacing.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2265
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

All patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.

Exclusion Criteria:

  • Acute ST segment myocardial infarction
  • Known sensitivity or contraindication to the agents planned for administration during coronary angiography
  • Pacemaker dependent patients
  • Pregnancy
  • Hypotension (a systolic blood pressure lower than 90mmHg) that would preclude the administration of adenosine
  • Severe renal dysfunction, defined as a estimated glomerular filtration (eGFR) less than 30ml/min, confirmed by recent testing
  • Study subject has any underlying disorder that, in the opinion of the investigator, precludes them from giving informed consent at the time of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Right ventricular Pacemaker
Patients with right ventricular pacing and evidence of coronary ischemia who have evidence of coronary ischemia who are to undergo coronary angiogram.When an intermediate stenosis (40-80%) has been identified angiographically, this lesion will undergo further hemodynamic assessment, All data including resting flow, FFR, CFR, vital signs, arrhythmias and patient symptoms will be recorded twice: once when the pacemaker is programmed to pace, and once when the PPM is reprogrammed such that the pacemaker is no longer pacing.
Diagnostic test: Coronary flow and pressure measurement in patients with ventricular pacing
Coronary flow and pressure measurement in patients with ventricular pacing
Other: Biventricular Pacemaker
Patients with Biventricular pacing and evidence of coronary ischemia who have evidence of coronary ischemia who are to undergo coronary angiogram.When an intermediate stenosis (40-80%) has been identified angiographically, this lesion will undergo further hemodynamic assessment, All data including resting flow, FFR, CFR, vital signs, arrhythmias and patient symptoms will be recorded twice: once when the pacemaker is programmed to pace, and once when the PPM is reprogrammed such that the pacemaker is no longer pacing.
Diagnostic test: Coronary flow and pressure measurement in patients with ventricular pacing
Coronary flow and pressure measurement in patients with ventricular pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR
Time Frame: Up to 12 months
Microvascular dysfunction with pacing
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR
Time Frame: Up to 12 months
Microvascular dysfunction with pacing
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Nashwa Abdulsalam, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2020

Primary Completion (Actual)

October 7, 2021

Study Completion (Actual)

October 7, 2021

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0898-18-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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