Internal Microstructure of Patent Foramen Ovale Related to Stroke (IMPORT)

July 17, 2025 updated by: China National Center for Cardiovascular Diseases

Internal Microstructure of Patent Foramen Ovale Related to Cryptogenic Stroke, Transient Ischemic Attack or Migraine

This study aims to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these patients; (2) evaluate the microstructural features of asymptomatic patients with PFO and make a follow-up；(3) perform an untargeted metabolomics analysis using plasma samples from right atrium and left atrium and shunt provocative test was conducted;(4) collect the blood sample from PFO tunnel;(5) cardiac CTA was performed to evaluate the position and morphology of device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patent foramen ovale (PFO) is associated with a variety of pathological conditions, and it is presumed to be related to the occurrence of cryptogenic stroke (CS), transient ischemic attack (TIA) or migraine. In addition, the main hypothesized pathophysiologic mechanism is paradoxical embolization, namely microemboli or metabolites from the venous circulation to enter the systemic circulation. The morphological characteristics of PFO have the potential to predict risks and screen the appropriate candidates for transcatheter closure. The structure features for predicting risk included atrial septal aneurysm, a large right-left shunt, long-tunnel PFO and so on. However, the in-vivo internal microstructure of PFO is still unclear. The microstructural features might provide important information for better understanding the PFO and risk stratification.

The aim of this study is to (1) investigate the internal microstructure of patent foramen ovale related to cryptogenic stroke, transient ischemic attack or migraine and determine the effectiveness of transcatheter closure in these patients; (2) evaluate the microstructural features of asymptomatic patients with PFO and make a follow-up；(3) perform an untargeted metabolomics analysis using plasma samples from right atrium and left atrium and shunt provocative test was conducted;(4) collect the blood sample from PFO tunnel;(5) cardiac CTA was performed to evaluate the position and morphology of device.

This study will enroll subjects with PFO, and enrollment will be divided into three phases.

Phase 1: PFO patients with CS or/and TIA (transcatheter closure of PFO was performed). A minimum of 500 patients is reached.

Phase 2: PFO patients with migraine (transcatheter closure of PFO was performed). A minimum of 500 patients is reached.

Phase 3: PFO patients without symptom (5-year follow-up). A minimum of 200 patients is reached.

In addition, blood samples were obtained, including inferior vena cava, superior vena cava, right atrium, PFO-tunnel, left pulmonary artery, left atrium and left pulmonary vein. Then, another 20 ml blood sample was obtained from right atrium (near PFO) and injected into left atrium immediately. During a ten-minute waiting period, any symptom was recorded.

Study Type

Observational

Enrollment (Estimated)

1200

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences,Fuwai Hospital
        • Contact:
          • Chaowu Yan, PhD and MD
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Chaowu Yan
        • Contact:
        • Principal Investigator:
          • Chaowu Yan, PhD and MD

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll subjects with PFO, and enrollment will be divided into three cohorts.

Cohort 1: PFO patients with CS or/and TIA (transcatheter closure of PFO was performed). A minimum of 100 patients is reached.

Cohort 2: PFO patients with migraine (transcatheter closure of PFO was performed). A minimum of 100 patients is reached.

Cohort 3: PFO patients without symptom (5-year follow-up). A minimum of 100 patients is reached.

Description

Inclusion Criteria:

  1. Patients aged 16 to 65 years without any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity;
  2. Documented PFO with right-to-left shunt ≥ 20 micro-bubbles by c-TCD;
  3. Stroke group: history of ischemic stroke (based on brain magnetic resonance imaging) or TIA within 6 months without other identifiable causes (Phase1);
  4. Migraine group: history of migraine headaches more than one year without other identifiable causes (Phase2);
  5. Control group: incidental finding of PFO without neurological or systemic symptoms (Phase3).

Exclusion Criteria:

  1. Any identifiable cause of ischemic stroke/TIA or migraine other than PFO;
  2. History of stroke or TIA within the past one month;
  3. Presence of cardiac enlargement or dysfunction;
  4. Presence of coexisting cardiovascular structural malformations/diseases;
  5. Presence of carotid artery lesions or coronary artery disease;
  6. Presence of deep vein thrombosis or pulmonary embolism;
  7. Presence of implanted cardiac devices;
  8. Evidence of hypercoagulable state;
  9. Allergic to contrast medium;
  10. Echocardiographic evidence of intra-cardiac thrombus, mass, tumor or vegetation;
  11. Active endocarditis or other infections.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PFO patients with CS or/and TIA
PFO patients with CS or/and TIA (transcatheter closure of PFO was performed).
Other: not appliable
not appliable
PFO patients with migraine
PFO patients with migraine (transcatheter closure of PFO was performed).
Other: not appliable
not appliable
PFO patients without symptom
PFO patients without symptom (5-year follow-up).
Other: not appliable
not appliable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events after evaluation of PFO internal microstructure
Time Frame: 5 years
cryptogenic stroke, transient ischemic attack , migraine or systemic embolism
5 years

Collaborators and Investigators

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

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Beijing Tiantan Hospital
Xuanwu Hospital, Beijing
Beijing Anzhen Hospital
The Affiliated Hospital of Xuzhou Medical University
Tibet Autonomous Region People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 23, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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