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

Coronary Microvascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03917251
• Other study ID #: 0898-18-FB
• Status: Withdrawn
• Phase: N/A
• Start date: December 2020
• Est. completion date: October 7, 2021

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will examine role of transvenous pacing on coronary microcirculation.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Pacemaker Syndrome
• Coronary Microvascular Disease
• Microvascular Angina

Intervention

Diagnostic Test:
• Coronary flow and pressure measurement in patients with ventricular pacing
Coronary flow and pressure measurement in patients with ventricular pacing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR	Microvascular dysfunction with pacing	Up to 12 months
Secondary	Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR	Microvascular dysfunction with pacing	Up to 12 months