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Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated.
The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - standard of care: Self-Directed Valsalva maneuver | Sham Comparator | The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium. |
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| Intervention arm: Goal-Directed Valsalva maneuver | Active Comparator | For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Intervention arm: Goal-Directed Valsalva maneuver | Device | For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver. | From enrollment to the end of echocardiogram (40 minutes from enrollment). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of large shunt positive bubble study. | From enrollment to the end of echocardiogram (40 minutes from enrollment). | |
| Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver in women and in men. | From enrollment to the end of echocardiogram (40 minutes from enrollment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Messika-Zeitoun, MD | Contact | 6136967337 | dmessika-zeitoun@ottawaheart.ca | |
| Roja Gauda, Masters of Applied Science | Contact | 6136967000 | 15310 | rgauda@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. David Messika-Zeitoun, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Not yet recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34756394 | Background | Bernard S, Churchill TW, Namasivayam M, Bertrand PB. Agitated Saline Contrast Echocardiography in the Identification of Intra- and Extracardiac Shunts: Connecting the Dots. J Am Soc Echocardiogr. 2020 Oct 23:S0894-7317(20)30615-5. doi: 10.1016/j.echo.2020.09.013. Online ahead of print. | |
| 31211145 | Background |
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A blinded comparative crossover diagnostic accuracy study
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|
| Control - standard of care: Self-Directed Valsalva maneuver | Device | The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium. |
|
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
|
| Zhao E, Du Y, Xie H, Zhang Y. Modified Method of Contrast Transthoracic Echocardiography for the Diagnosis of Patent Foramen Ovale. Biomed Res Int. 2019 May 9;2019:9828539. doi: 10.1155/2019/9828539. eCollection 2019. |
| 28902593 | Background | Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, Arquizan C, Bejot Y, Vuillier F, Detante O, Guidoux C, Canaple S, Vaduva C, Dequatre-Ponchelle N, Sibon I, Garnier P, Ferrier A, Timsit S, Robinet-Borgomano E, Sablot D, Lacour JC, Zuber M, Favrole P, Pinel JF, Apoil M, Reiner P, Lefebvre C, Guerin P, Piot C, Rossi R, Dubois-Rande JL, Eicher JC, Meneveau N, Lusson JR, Bertrand B, Schleich JM, Godart F, Thambo JB, Leborgne L, Michel P, Pierard L, Turc G, Barthelet M, Charles-Nelson A, Weimar C, Moulin T, Juliard JM, Chatellier G; CLOSE Investigators. Patent Foramen Ovale Closure or Anticoagulation vs. Antiplatelets after Stroke. N Engl J Med. 2017 Sep 14;377(11):1011-1021. doi: 10.1056/NEJMoa1705915. |
| 24689727 | Background | Mojadidi MK, Winoker JS, Roberts SC, Msaouel P, Zaman MO, Gevorgyan R, Tobis JM. Accuracy of conventional transthoracic echocardiography for the diagnosis of intracardiac right-to-left shunt: a meta-analysis of prospective studies. Echocardiography. 2014 Oct;31(9):1036-48. doi: 10.1111/echo.12583. Epub 2014 Apr 2. |
| 26765302 | Background | Saric M, Armour AC, Arnaout MS, Chaudhry FA, Grimm RA, Kronzon I, Landeck BF, Maganti K, Michelena HI, Tolstrup K. Guidelines for the Use of Echocardiography in the Evaluation of a Cardiac Source of Embolism. J Am Soc Echocardiogr. 2016 Jan;29(1):1-42. doi: 10.1016/j.echo.2015.09.011. |
| 33709114 | Background | Cohen A, Donal E, Delgado V, Pepi M, Tsang T, Gerber B, Soulat-Dufour L, Habib G, Lancellotti P, Evangelista A, Cujec B, Fine N, Andrade MJ, Sprynger M, Dweck M, Edvardsen T, Popescu BA; Reviewers: This document was reviewed by members of the 2018-2020 EACVI Scientific Documents Committee; chair of the 2018-2020 EACVI Scientific Documents Committee. EACVI recommendations on cardiovascular imaging for the detection of embolic sources: endorsed by the Canadian Society of Echocardiography. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):e24-e57. doi: 10.1093/ehjci/jeab008. |
| 28154102 | Background | Yaghi S, Bernstein RA, Passman R, Okin PM, Furie KL. Cryptogenic Stroke: Research and Practice. Circ Res. 2017 Feb 3;120(3):527-540. doi: 10.1161/CIRCRESAHA.116.308447. |
| 29495983 | Background | Mojadidi MK, Zaman MO, Elgendy IY, Mahmoud AN, Patel NK, Agarwal N, Tobis JM, Meier B. Cryptogenic Stroke and Patent Foramen Ovale. J Am Coll Cardiol. 2018 Mar 6;71(9):1035-1043. doi: 10.1016/j.jacc.2017.12.059. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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