Does Patent Foramen Ovale Size Matter in Men and Women

October 12, 2022 updated by: University of Oregon
A patent foramen ovale (PFO) is present in ~30% of the general population. The PFO has historically been considered to be trivial. However, recent work by the investigator's group and others has identified that, compared to individuals without a PFO, those with a PFO have worse pulmonary gas exchange efficiency, have a higher core body temperature, blunted ventilatory responses to chronic hypoxia and acute carbon dioxide and increased susceptibility to altitude illnesses such as acute mountain sickness, and high altitude pulmonary edema (Lovering, Elliott & Davis J Appl Physiol 2016). Specific to this application,subjects with a PFO may have worse pulmonary gas exchange efficiency because a PFO is a potential source of right-to-left shunt that will make pulmonary gas exchange efficiency worse. If true, then this may negatively impact exercise capacity and/or exercise tolerance. Further, in those with a PFO compared to those without, preliminary work from the investigator's lab indicates that there may be an effect of PFO size on pulmonary gas exchange efficiency. This is such that those with a large PFO (grade 3 or higher) display significantly worse gas exchange efficiency compared to those with a small (grade 2 or lower) or no PFO,even at low exercise workloads. Additionally, the investigators were curious as to whether there would be a sex effect, but due to logistical constraints, the investigators were unable to recruit an equal number of female and male subjects. Thus, in addition to the potential size effect on the investigators outcome measures, the investigators would like to build on this work by examining the potential effect of biological sex. Although a PFO has been traditionally considered to have a minimal impact of physiology and pathophysiology, emerging evidence suggests this may not be the case. The investigator's lab is focused on understanding how and why a relatively small hole in the heart (PFO) can have a relatively large impact on cardiopulmonary and respiratory physiology, and how these impacts may be based on the size of the PFO.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Recruiting
        • Cardiorespiratory and Pulmonary Physiology Lab
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy adults aged 18-40 with and without a PFO.

Description

Inclusion Criteria:

  • Men and women aged 18-40
  • Known to have/not have a PFO.

Exclusion Criteria:

  • Previous history of coronary artery disease(ischemic heart disease such as angina, heart attack, myocardial infarction).
  • Failure of Modified Allen's Test in both hands.
  • Currently taking medications or herbal supplements for any heart or respiratory disease that they cannot stop taking for 48 hrsprior to testing (seasonal allergy medication not included in exclusion medications).
  • Lidocaine, nitroglycerine or heparin allergy.
  • Women who are pregnant or trying to become pregnant.
  • Previous history of any condition that would prevent the subject from performing cycle ergometer exercise (for exercise study only).

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
No PFO
Research subjects who present no evidence of PFO - IE no appearance of saline contrast microbubbles within 3 cardiac cycles
Small PFO
Research subjects who present evidence of having a small PFO or ASD - IE appearance of 1-11 saline contrast microbubbles within 3 cardiac cycles
Large PFO
Research subjects who present evidence of having a large PFO - IE appearance of 12+ saline contrast microbubbles within 3 cardiac cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
alveolar-arterial difference in oxygen
Time Frame: Baseline
difference in the partial pressure of oxygen between the alveoli (calculated) and arterial blood (direct measure)
Baseline
aerobic exercise capacity
Time Frame: Baseline
ability to utilize oxygen while exercising, AKA Vo2MAX
Baseline
six-minute walk test
Time Frame: Baseline
distance covered in 6 minutes of walking
Baseline
minute flow of intrapulmonary areterio-venous anastamoses (QIPAVA)
Time Frame: Baseline
minute flow through intrapulmonary arteriovenous anastamoses
Baseline
core body temperature
Time Frame: Baseline
subject's core body temperature as measured through an ingestible pill
Baseline
level of tumor necrosis factor alpha
Time Frame: Baseline
inflammatory marker
Baseline
level of C-C motif cytokine 2
Time Frame: Baseline
inflammatory marker
Baseline
level of interferon alpha 2
Time Frame: Baseline
inflammatory marker
Baseline
level of interferon gamma
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 1 beta
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 6
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 8
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 10
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 12p70
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 17 alpha
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 18
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 23
Time Frame: Baseline
inflammatory marker
Baseline
level of interleukin 33
Time Frame: Baseline
inflammatory marker
Baseline
level of myoglobin
Time Frame: Baseline
inflammatory marker
Baseline
level of myeloid-related protein 8/14
Time Frame: Baseline
inflammatory marker
Baseline
level of neutrophil gelatinase-associated lipocalin
Time Frame: Baseline and 3 months post percutaneous closure
inflammatory marker
Baseline and 3 months post percutaneous closure
level of c-reactive protein
Time Frame: Baseline
inflammatory marker
Baseline
matrix metallopeptidase 2
Time Frame: Baseline and 3 months post percutaneous closure
inflammatory marker
Baseline and 3 months post percutaneous closure
level of osteopontin
Time Frame: Baseline
inflammatory marker
Baseline
level of myloperoxidase
Time Frame: Baseline
inflammatory marker
Baseline
level of Serum amyloid A
Time Frame: Baseline
inflammatory marker
Baseline
level of insulin like growth factor binding protein 4
Time Frame: Baseline
inflammatory marker
Baseline
level of intracellular adhesion molecule 1
Time Frame: Baseline
inflammatory marker
Baseline
level of vascular cell adhesion protein 1
Time Frame: Baseline
inflammatory marker
Baseline
level of metallopeptidase 9
Time Frame: Baseline
inflammatory marker
Baseline
level of Cystatin C
Time Frame: Baseline
inflammatory marker
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oregon

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04302018.049

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

No

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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