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

• Sponsor: University of Nebraska (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03917251
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4.9
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Feb 28, 2021
• Anticipated Study Completion Date: Apr 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR [Up to 12 months]

   Microvascular dysfunction with pacing

Secondary Outcome Measures

1. Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR [Up to 12 months]

   Microvascular dysfunction with pacing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-2265

Sponsors and Collaborators

• University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nashwa Abdulsalam, General Cardiology fellow, University of Nebraska
• ClinicalTrials.gov Identifier: NCT03917251
• Other Study ID Numbers: 898-18
• First Posted: Apr 17, 2019
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Nashwa Abdulsalam, General Cardiology fellow, University of Nebraska: coronary microvascular dysfunction
• Additional relevant MeSH terms: Microvascular Angina

Study Results

No Results Posted as of Sep 4, 2020