CODICIA
Recurrent Cryptogenic Stroke and Right to Left Shunt
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Status:
As of January 2008, enrollment has been completed with 486 enrolled at 17 hospitals. Results available and published in September 2008.
Purpose:
To compare the risk of recurrent stroke in cryptogenic stroke patients who have a patent foramen ovale with right-to-left shunting (RLSh) with the risk of recurrence in cryptogenic stroke (CS) patients with normal cardiac anatomy.
Year Started:
2000
Year Finished:
2007
Design:
Multicenter trial with a planned enrollment of 500 patients at 20 centers.
Inclusion Criteria
Patients who present within 30 days of cryptogenic stroke, defined by the TOAST criteria, are eligible for this study.
Patient Involvement:
Eligible patients will undergo contrast transcranial Doppler ultrasonography (TCD) with saline solution infusion. RLSh will be quantified by counting the number of contrast signals that appear in the middle cerebral artery (MCA) when the patient performs the Valsalva maneuver. Contrast signal patterns on TCD will be characterized as either no shunt (0 signals), small (<10 signals), large (10-25 signals), shower (>25 signals), or curtain (uncountable signals). Subsequently, patients with massive RLSh will receive contrast TEE, while those without RLSh will receive either contrast TEE or transthoracic echocardiography (TTE). All patients will have a clinical follow-up visit at 3 months and will be followed annually by telephone contact for the 3-year duration of the study.
Primary Outcome:
Incidence of transient ischemic attack (TIA) and recurrent stroke.
Secondary Outcome:
Correlation between RLSh magnitude and frequency of recurrent stroke; influence of other minor potential sources of embolism, especially atrial septal aneurysm (ASA), detected by transesophageal echocardiography (TEE) in patients with RLSh; protective effect of antiplatelet and anticoagulant drugs in CS patients with RLSh; correlation between RLSh magnitude and Canadian Stroke Scale, modified Rankin Scale, and Barthel Index scores.
Results:
Massive RLSh was detected in 200 patients (41.2%). The mean follow-up was 729±411 days. Stroke recurrence was low (5.8%, n=28) and similar in patients with massive RLSh, with nonmassive RLSh, and with no RLSh, in both the younger group (3.4% vs 2.3% vs 4.5%, respectively; P=0.75) and in the whole population (5.0% vs 6.2% vs 6.3%, respectively; P=0.58). Regression analysis found no association between massive RLSh and recurrent stroke in either group (in the whole population, odds ratio=0.94; 95% CI, 0.36 to 2.40; P=0.89; in the younger population, odds ratio=0.93; 95% CI, 0.18 to 4.91; P=0.93). These results were similar when concurrent atrial septal aneurysm and massive RLSh were analyzed and when antithrombotic treatment and concomitant stroke risk factors were included. These results suggest that neither massive RLSh nor massive RLSh with concurrent atrial septal aneurysm is an independent risk factor for recurrent stroke, in either the general or younger stroke populations.
Source of Information:
Correspondence with trial coordinator. Presented at the European Stroke Conference (May 2001).
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This information last updated on: 4/27/2009
Reviewed on: 04/27/2009.
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