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

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ClinicalTrials.gov Identifier: NCT03917251
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Nashwa Abdulsalam, University of Nebraska

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Microvascular Disease Cardiac Pacemaker Syndrome Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021
Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR [ Time Frame: Up to 12 months ]
    Microvascular dysfunction with pacing


Secondary Outcome Measures :
  1. Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR [ Time Frame: Up to 12 months ]
    Microvascular dysfunction with pacing


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917251


Contacts
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Contact: Nashwa Abdulsalam 4025595151 nashwa.abdulsalam@unmc.edu

Locations
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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-2265
Sponsors and Collaborators
University of Nebraska
More Information
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Responsible Party: Nashwa Abdulsalam, General Cardiology fellow, University of Nebraska
ClinicalTrials.gov Identifier: NCT03917251    
Other Study ID Numbers: 898-18
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nashwa Abdulsalam, University of Nebraska:
coronary microvascular dysfunction
Additional relevant MeSH terms:
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Microvascular Angina
Angina Pectoris
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases