Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
Phase: NA
Conditions: Ventricular Dysfunction, Pericardial Effusion, Valvular Disease, Septal Defect
Sponsor: University of Miami

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Title:  C o m paris o n of dia g n ostic a bilit y of f oc us e d car diac ultras o u n d usi n g a n F D A 
a p pr o ve d ha n d-hel d ultras o u n d de vice wit h sta n dar d tra nst h oracic 
ec h ocar di o gra m i n o ut patie nt setti n g i n o ur i nstit uti o n. 
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Versi o n  N u m ber: # 1 
e Pr ost I D:  2 0 1 8 1 0 8 9 
PI N a me:  Mar y S o k ol os ki, M D 
N C T N u m be r:   N C T 0 3 8 8 7 2 8 6 

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1.  Pr ot oc ol Title  
C o m paris o n of dia g n ostic a bilit y  of f oc us e d car diac ultras o u n d usi n g a n F D A 
a p pr o ve d ha n d- hel d ultras o u n d de vice wit h sta n dar d tra nst h oracic ec h ocar di o gra m i n 
o ut patie nt setti n g  i n o ur i nstit uti o n. 
 
2.  O bjecti ves * 
a) T o c o m pare t he dia g n ostic a bilit y of f oc us e d car diac ultras o u n d  usi n g a n F D A 
a p pr o ve d ha n d-hel d ultras o u n d de vice i n assessi n g car diac a nat o m y, f u ncti o n a n d 
pericar dial eff usi o n wit h sta n dar d tra nst h oracic ec h ocar di o gra m i n o ut patie nt 
setti n g i n o ur i nstit uti o n. 
b)  T o pr o p ose p ossi ble strate gies f or usi n g f o c use d car diac ultras o u n d i n vari o us 
a p pr o priate cli nical setti n gs i n o ur i nstit uti o n.  
 
3.  B ac k gr o u n d * 
Car diac ultras o u n d is se nsiti ve a n d s pecific f or dia g n osi n g a wi de arra y of cli nical 
dis or ders. I n t he fiel d of car di ol o g y, ultras o u n d is use d acr oss t he e ntire s pectr u m of 
patie nt care, fr o m fet us t o el derl y. A d va nce d i ma gi n g ca pa bilities, s uc h as t hree -
di me nsi o nal ( 3 D) a n d strai n i ma gi n g, are i nc or p orate d i n car diac ultras o u n d i n a n 
eff ort t o i ncrease t he dia g n ostic val ue. I n rece nt years, wit h t he de vel o p me nt of 
mi niat urize d ultras o u n d s yste ms, t here is p ote ntial t o c ha n ge t he practice of car diac 
ultras o u n d. T hese de vices ha ve t he a d va nta ge of s maller size, l o wer c ost a n d 
si m plifie d o perati o n i n c o m paris o n wit h t he sta n dar d tra nst h oracic ec h ocar di o gra p hic 
( T T E) de vices. Gi ve n t he wi des prea d a vaila bilit y of mi niat urize d ultras o u n d s yste ms, 
se veral st u dies ha ve de m o nstrate d t hat t hese ne wer de vices w he n use d i n a p pr o priate 
c o n diti o ns ma y pr o vi de dia g n ostic yiel d c o m para ble t o t hat of sta n dar d T T E, wit h 
re gar ds t o basic ec h ocar di o gra p hic para meters. T his st u d y is desi g ne d t o 
pr os pecti vel y e val uate t he feasi bilit y a n d di a g n ostic acc urac y of f oc use d car diac 
ultras o u n d ( F C U) usi n g t he ha n d- hel d ultras o u n d de vice i n c o m paris o n wit h f ull 
f u ncti o nalit y T T E i n o ur i nstit uti o n i n o ut patie nt setti n g. T he res ult of t his st u d y will 
ma ke a n i m p orta nt c o ntri b uti o n t o wi de n t he s pectr u m of p ote ntial usa ge of F C U. 

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T here b y, strate gies f or usi n g F C U i n vari o us a p pr o priate cli nical setti n gs c o ul d be 
i m ple me nte d. 
 
4.  I ncl usi o n a n d E xcl usio n Criteri a *  
I ncl usi o n criteria:  
•  Patie nts prese nti n g t o pe diatric car di ol o g y cli nic at H oltz C hil dre n’s h os pital 
re q uiri n g c o m pre he nsi ve or li mite d tra nst h oracic ec h ocar di o gra m  ( T T E). 
•  Willi n g a n d a ble t o pr o vi de i nf or me d c o nse nt or asse nt. 
•  I n cli nicall y sta ble c o n diti o n as assesse d b y t he pri nci pal i n vesti gat or . 
•  Wit h a d e q uate ec h ocar di o gra p hic wi n d o ws. 
E xcl usi o n criteria:  
•  Patie nts wit h p o or ec h ocar di o gra p hic wi n d o ws. 
•  Patie nts w h o ref use i nf or me d c o nse nt. 
•  Pre g na nt w o me n. 
•  Pris o ners.   
•  Patie nts dee me d u nfit t o partici pate i n t he cli nical trial as assesse d b y t he 
pri nci pal i n vesti gat or.  
 
5.  Pr oce d ures I n v ol ve d *  
T he st u d y will ta ke place i n J ac ks o n Me m orial H os pital/ U ni versit y of Mia mi, Mia mi. 
T he st u d y will be c o n d ucte d i n o ut patie nt pe diatric car di ol o g y cli nic. Patie nts 
prese nti n g f or car diac e val uati o n re q uiri n g a sta n dar d c o m pre he nsi ve or li mite d T T E 
wit h a de q uate ec h ocar di o gra p hic vie ws, will be i ncl u de d i n t he st u d y. A n i nf or me d 
c o nse nt will be o btai ne d pri or t o partici pati o n fr o m all s u bjects or t heir  pare nt s if t he 
s u bject is a mi n or. T he me dical rec or d n u m ber ( M R N) a n d reas o n f or referral f or 
car diac e val uati o n will be c ollecte d fr o m me dical rec or ds.  
T he s u bjects  i ncl u de d i n t he st u d y will first u n der g o car diac e val uati o n wit h a 
stan dar d T T E usi n g P hili ps E PI Q 7 u ltras o u n d mac hi ne. T T E will be c o m pre he nsi ve 
or li mite d base d o n t he cli nical i n dicati o ns. I m me diatel y after t he sta n dar d T T E, the 
sa me s u bject will t he n u n der g o F C U usi n g a n F D A a p pr o ve d ha n d- hel d ultras o u n d 
de vice ( P hili ps L u mif y br oa d ba n d sect or  arra y tra ns d ucer). T he P hili ps L u mif y 
br oa d ba n d sect or arra y tra ns d ucer has recei ve d 5 1 0( k) cleara nce fr o m t he U. S. F o o d 
a n d Dr u g A d mi nistrati o n ( F D A) w hic h was a n n o u nce d at t he A merica n C olle ge of 
E mer ge nc y P h ysicia ns’ ( A C E P) a n n ual meeti n g  i n Oct o ber 2 0 1 6. T he P hili ps l u mif y 
p orta ble ultras o u n d pr o be will be pl u g ge d i n t o a Sa ms u n g Gala x y Ta blet S 3. L u mif y 
a p p will be i nstalle d i n t he Sa ms u n g Gala x y Ta blet S 3 w hic h will be pass w or d 
pr otecte d. T he ec h ocar di o gra p hic i ma ges will be vie we d a n d st ore d i n L u mi f y a p p. 
T he i ma ges will s u bse q ue ntl y be tra nsferre d t o U ni versit y of Mia mi P hili ps Xcelera 
s yste m, w here it will be st ore d f or 6 years. A p pr o val f or t he usa ge of Sa ms u n g 
Gala x y Ta blet S 3 is o btai ne d fr o m de part me nt of bi o me dical e n gi neeri n g at J ac ks o n 
Me m orial H os pital. A p pr o val f or st ori n g i ma ges i n U ni versit y of Mia mi P hili ps 
Xcelera s yste m is o btai ne d fr o m t he de part me nt of i nf or mati o n tec h n ol o g y (I T).  F or 
F C U , t he i ma ges will be o btai ne d i n s u bc ostal, a pical, paraster nal l o n g, a n d 
paraster nal s h ort a xis vie ws t o assess car diac a nat o m y, left ve ntric ular s yst olic 
f u ncti o n a n d pericar dial eff usi o n. All T T E i ma ges will be perf or me d b y a pe diatric 

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car di ol o g y fell o w or a re gistere d dia g n ostic car diac s o n o gra p her ( R D C S). All F C U 
i ma ges will be o btai ne d b y a pe diatric car di ol o g y fell o w w h o will be bli n de d f or 
fi n di n gs i n T T E. T T E will be i nter prete d a n d re p orte d b y a n e x pert pe diatric 
car di ol o g y atte n di n g p h ysicia n . F C U usi n g ha n d- hel d ultras o u n d will be i nter prete d 
a n d re p orte d b y a n ot her e x pert pe diatric car di ol o g y atte n di n g p h ysicia n  w h o will be 
bli n de d f or fi n di n gs i n T T E . T he s u m mar y re p ort will i ncl u de t he car diac a nat o m y, 
left ve ntric ular s yst olic f u ncti o n, a n d pericar dial eff usi o n. F or eac h patie nt i ncl u de d i n 
t he st u d y, t he fi n di n gs of T T E will be c o m pare d wit h t hat of F C U. T he data o btai ne d 
will be statisticall y a nal yze d as bel o w.  
 
6.  D at a St or a ge * 
Rele va nt c o de d data w o ul d be st ore d i n f or m of Micr os oft E xcel S prea ds h eet i n a 
st ora ge dri ve accessi ble t o t he PI a n d t he sec o n dar y i n vesti gat ors e xcl usi vel y. T he 
dri ve w o ul d be pass w or d pr otecte d li miti n g t he access t o pri mar y a n d sec o n dar y 
i n vesti gat ors o nl y. T he data w o ul d be st ore d f or si x years f oll o wi n g st u d y cl os ure. 
 
7.  D at a M a n a ge me nt * 
Data will be a nal yze d usi n g S P S S s oft war e creati n g fre q ue nc y ta bles, tests of 
si g nifica nce a n d u ni variate a n d m ulti variate a nal ysis. 
Data c ollecte d will be c o de d, de-i de ntifie d a n d st ore d p h ysicall y i n a pass w or d 
pr otecti ve dri ve wit h li mite d access. All t he  c o de d data tra ns mitte d electr o nicall y 
w o ul d be t hr o u g h sec ure d mail s yste m of J ac ks o n Healt h s yste m.  
 
8.  Ris ks t o S u bjects *  
Ultras o u n d is ge nerall y c o nsi der e d safe wit h ver y l o w ris ks. F C U i n v ol ves sta n dar d 
ris ks ass ociate d wit h ultras o u n d. 
Patie nt i nf or mati o n will be c ollecte d. Alt h o u g h e ver y meas ure will be ta ke n i n or der 
t o pre ve nt a n y p ossi ble c o m pr o mise of patie nt data (safe st ora ge, pass w or d 
e ncr y pti o n, li mite d access, etc), t he ris ks ass ociate d wit h p ossi ble discl os ure of 
p atie nt data are prese nt. T he ris ks i ncl u de attai n me nt of patie nt i nf or mati o n b y s o me 
t hir d part y – h o w t he y c o ul d use t his i nf or mati o n e ve n if it were c o m pr o mise d, is n ot 
easil y f oresee n. I de ntif yi n g varia bles ( na me, M R N, etc) will n ot be st ore d t o 
mi ni mize t he ris ks, si m pl y t he varia bles t hat we are i ntereste d i n. Alt h o u g h discl os ur e 
of patie nt i nf or mati o n is c o nce pt uall y p ossi ble, it is hi g hl y u nli kel y seei n g as h o w w e 
will ta ke e ver y p ossi ble preca uti o n a n d n ot st ore a n y i de ntif yi n g i nf or mati o n  
 
9.  P ote nti al Be nefits t o S u bjects * 
T here is n o direct be nefit b ut b y st u d yi n g t he dia g n ostic acc urac y of F C U usi n g ha n d-
hel d ultras o u n d de vice i n assessi n g car diac a nat o m y, f u ncti o n a n d pericar dial eff usi o n 
i n c o m paris o n wit h c o m pre he nsi ve T T E. H o we ver, base d o n t he fi n di n gs fr o m t he 
st u d y, we ca n pr o p ose p ossi ble strate gies f or usi n g F C U i n vari o us a p pr o priate 
cli nical setti n gs i n o ur i nstit uti o n.   

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1 0.  V ul ner a ble P o p ul ati o ns *  
T he st u d y i n v ol ves s u bjects w h o ha ve n ot attai ne d t he le gal a ge of c o nse nt t o 
treat me nts or pr oce d ures, a n d a writte n c o nse nt will be o btai ne d fr o m s u bject’s 
pare nts. 
 
1 1.  Setti n g  
T he st u d y will ta ke place i n J ac ks o n Me m orial H os pital/ U ni versit y of Mia mi, Mia mi. 
T he st u d y will be c o n d ucte d i n o ut patie nt pe diatric car di ol o g y cli nic. Patie nts 
prese nti n g f or car diac e val uati o n re q uiri n g a sta n dar d c o m pre he nsi ve or li mite d 
tra nst h oracic ec h ocar di o gra m ( T T E) wit h a de q uate ec h ocar di o gra p hic vie ws, will be 
i ncl u de d i n t he st u d y. A n i nf or me d c o nse nt will be o btai ne d pri or t o partici pati o n 
fr o m all s u bjects or t heir pare nts  if t he s u bject is a mi n or.  
 
1 2.  Res o urces A v ail a ble 
a. T he F C U will be perf or me d b y a pe diatric car di ol o g y fell o w (sec o n dar y 
i n vesti gat or) w h o is trai ne d i n perf or mi n g a n d i nter preti n g t he car diac 
ultras o u n d.  
b.  T he st u d y will be i nter prete d a n d t he fi n di n gs will be c o m pare d t o t he fi n di n gs 
fr o m sta n dar d T T E b y a pe diatric car di ol o g y atte n di n g  ( pri nci pal 
i n vesti gat or). 
c. Data c ollecti o n a n d a nal ysis will be d o ne b y t he sec o n dar y i n vesti gat or.  
 
1 3.  Pri or A p pr o v als  
N o ne 
 
1 4.  Recr uit me nt Met h o ds  
T he st u d y will ta ke place i n J ac ks o n Me m orial H os pital/ U ni versit y of Mia mi, Mia mi. 
T he st u d y will be c o n d ucte d i n o ut patie nt pe diatric car di ol o g y cli nic.  T he me dical 
rec or d n u m ber a n d t he i n dicati o n f or car diac e val uati o n will be o btai ne d b y re vie wi n g 
t he patie nt’s electr o nic me dical rec or d. Patie nts prese nti n g f or car diac e val uati o n t o 
o ut patie nt car di ol o g y cli nic re q uiri n g a sta n dar d c o m pre he nsi ve or li mite d T T E wit h 
a de q uate ec h ocar di o gra p hic vie ws, will be i ncl u de d i n t he st u d y . O n i n di vi d uals 
meeti n g t he i ncl usi o n criteria as a b o ve, u p o n c o m pleti o n of t he sta n dar d T T E, a 
writte n c o nse nt will be o btai n e d b y t he st u d y c o or di nat or t o be i ncl u de d i n t he st u d y. 
I n di vi d uals ref usi n g c o nse nt will be e xcl u de d fr o m t he st u d y. 
 
1 5.  L oc al N u m ber of S u bjects  
We e x pect a b o ut  4 0 pe o ple here will be i n t his researc h st u d y.  
 
1 6.  Pr o visi o ns t o Pr otect t he Pri v ac y I nterests of S u bjects  
Data will be c ollecte d a n d st ore d usi n g a n u m ber t o i de ntif y eac h patie nt i n place of 
t heir na me. T he fi nal data s heet a n d t he res ults of t he st u d y w o ul d be de v oi d of 

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i de ntifiers. T he i de ntificati o ns w o ul d be use d strictl y f or preli mi nar y data gat heri n g 
o nl y a n d w o ul d n ot be use d f or a n y ot her p ur p ose t ha n t his st u d y al o ne. 
 
1 7.  C o nse nt Pr ocess  
A writte n c o nse nt f or m will be o btai ne d fr o m t he patie nt i n pe diatric car di ol o g y cli nic 
d uri n g t he cli nic visit.   
F or s u bjects bel o w 1 8 years of a ge, writte n  c o nse nt f or m will be o btai ne d fr o m t he 
pare nt. 
F or s u bjects w h o s pea k S pa nis h, oral a n d writte n i nf or mati o n pr o vi de d t o t h ose 
s u bjects will be i n S pa nis h.