Back to resultsThe Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Primary Purpose
Coronary Microvascular Disease, Cardiac Pacemaker Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronary flow and pressure measurement in patients with ventricular pacing
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Microvascular Disease focused on measuring coronary microvascular dysfunction
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Right ventricular Pacemaker
Biventricular Pacemaker
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR
Microvascular dysfunction with pacing
Secondary Outcome Measures
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR
Microvascular dysfunction with pacing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917251
Brief Title
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Official Title
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI left the institution
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
October 7, 2021 (Actual)
Study Completion Date
October 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will examine role of transvenous pacing on coronary microcirculation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microvascular Disease, Cardiac Pacemaker Syndrome
Keywords
coronary microvascular dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right ventricular Pacemaker
Arm Type
Other
Arm Description
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.
Arm Title
Biventricular Pacemaker
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Coronary flow and pressure measurement in patients with ventricular pacing
Intervention Description
Coronary flow and pressure measurement in patients with ventricular pacing
Primary Outcome Measure Information:
Title
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR
Description
Microvascular dysfunction with pacing
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR
Description
Microvascular dysfunction with pacing
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nashwa Abdulsalam, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
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