Coronary Microvascular DiseaseNCT03917251
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
A study testing Coronary flow and pressure measurement in patients with ventricular pacing in people with Coronary Microvascular Disease and Cardiac Pacemaker Syndrome, run by University of Nebraska.
Trial summary
The study will examine role of transvenous pacing on coronary microcirculation. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Microvascular Disease, Cardiac Pacemaker Syndrome
- What is being tested?
- Coronary flow and pressure measurement in patients with ventricular pacing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2021to 7 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.
Who cannot join
- 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
About this study
The study will examine role of transvenous pacing on coronary microcirculation.
Read the 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.
- Being tested
- Coronary flow and pressure measurement in patients with ventricular pacing
- Keywords
- coronary microvascular dysfunction
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary flow and pressure measurement in patients with ventricular pacingDiagnostic test
Coronary flow and pressure measurement in patients with ventricular pacing
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular Pacemaker | Other | 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. Receives: Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing |
| Biventricular Pacemaker | Other | 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. Receives: Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR
Microvascular dysfunction with pacing
Measured: Up to 12 months
Secondary outcomes (1)
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR
Microvascular dysfunction with pacing
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start7 Oct 2021 (estimated)
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nashwa Abdulsalam, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917251
- Sponsor's protocol ID
- 0898-18-FB
- Status last verified
- Aug 2024
- First submitted
- 3 Mar 2019
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
- ClinicalTrials.gov ID
- NCT03917251
- Acronym / sponsor ID
- 0898-18-FB
- Keywords
- coronary microvascular dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 7 Oct 2021 (estimated)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricular Pacemaker | Other | Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacingPatients 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. |
| Biventricular Pacemaker | Other | Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacingPatients 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary flow and pressure measurement in patients with ventricular pacingCoronary flow and pressure measurement in patients with ventricular pacing | Diagnostic test | Biventricular Pacemaker, Right ventricular Pacemaker |
Primary outcome
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR
Time frame: Up to 12 months
Microvascular dysfunction with pacing
1 secondary outcome
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nashwa Abdulsalam, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing Coronary flow and pressure measurement in patients with ventricular pacing in people with Coronary Microvascular Disease and Cardiac Pacemaker Syndrome, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.