- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03917251
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Withdrawn
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
-
-
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.
|
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.
|
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
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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