Clinical trial NCT01018355: The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
Official title: The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patent Foramen Ovale
PFO
Stroke
TIA
Keywords: Patent foramen ovale
PFO
Stroke
TIA
Percutaneus closure
Intervention
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2009-11-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to evaluate if patent foramen ovale (PFO) closure and antiplatelet medical management can reduce the risk of recurrent stroke or transient ischemic attack (TIA) when compared to antiplatelet medical management alone in elderly patients above 50 years of age with a PFO and a history of cryptogenic stroke or TIA.

Detailed description: Prior to birth the fetal heart has a connection between the two atrias of the heart. After labour this connection often closes. About 10-15 % these connections remains open. This phenomenon is called patent foramen ovale or PFO, and is in most cases unsymptomatic.

The prevalence of PFO in patients with crytogenic (without known causes) stroke is much higher (about 40%)than the general population (about 10%). This has led to the theory that the presence of PFO can lead to stroke, by the passage of emboli from the peripheral venous circulation through the PFO to the brain by right-to-left shunting of the blood.

There are no existing data from prospective randomized studies focusing on the effect of device closure PFO in patients with cryptogenic stroke. Some observational retrospective studies have shown a beneficial effect in the reduction of recurrent stoke in patients younger that 50 years with cryptogenic stroke when PFO has been closed with a percutaneous device closure(PCD). Some studies have reported an 0% to 3.4% annual recurrence rate of stroke or TIA in patients treated with PDC. The recurrence rate of stroke or TIA in patients with crytogenic stroke or TIA in ordinary antithrombotic treatment is about 5-15 %.

The primary objective of this study is to assess whether percutaneous device closure of patent foramen ovale is superior to conventional antithrombotic treatment in preventing stroke recurrence in elderly patients above 50 years of age.

Eligibility criteria: Inclusion Criteria:

* Stroke or TIA within 30 days
* Above 50 years of age

Exclusion Criteria:

* Deceases og the esophagus
* Dementia
* Allergy to aspirin
* Risk of non-compliance
* Lacking ability to give written or oral consent
* Atrial Fibrillation
* Neurological deficit lasting less than 6 hours

Primary outcomes:
measure: Combined endpoint defined by the time from intervention to either fatal og non-fatal stroke/TIA
timeFrame: Endpoints assessed every half year starting 1 year after intervention
Secondary outcomes:
measure: ct-verified stroke 2 years after intervention
timeFrame: 2 years after intervention
measure: Death by other causes than Stroke
timeFrame: Endpoint assessed every half year starting 1 year after intervention
measure: Examination of residual cardiac right to left shunt after device closure of PFO
timeFrame: 1 month after intervention
measure: Complications to device closure of PFO
timeFrame: few days after intervention
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Dept. of cardiology and endocrinology H
state: Region H
Study officials:
affiliation: Hillerød Hospital. dept. of cardiology and endocrinology
name: Christian S Hansen, dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hillerød Hospital. dept. of cardiology and endocrinology
name: Niels Tønder, Dr.
role: STUDY_DIRECTOR
affiliation: Hillerød Hospital. dept. of cardiology and endocrinology
name: Kasper K Iversen, Dr.
role: STUDY_DIRECTOR
References: