Coronary Disease Clinical Trial
Official title:
The Impact of Coronary Revascularization on Absolute Myocardial Blood Flow as Assessed by Stress Myocardial Positron Tomography
Verified date | October 2017 |
Source | Ochsner Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Regional absolute myocardial blood flow during stress (sMBF) as measured by Positron Emission Tomography (PET) improves post mechanical revascularization provided there is a baseline stress induced perfusion defect. Coronary revascularization performed on regions without a stress induced perfusion defect does not increase the sMBF.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | December 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals who undergo cardiac stress PET and subsequently undergo coronary angiography and mechanical revascularization. Mechanical revascularization is defined as PCI and/or coronary artery bypass grafting (CABG). - Adults =18 and able to give informed consent. Exclusion Criteria: - Individuals with acute ST-elevation myocardial infarction (< 3 days) - Individuals where absolute flow data is not available on the initial PET stress. - Individuals who are unable to perform PET scanning secondary to hemodynamic instability. - Individuals who are medically noncompliant with post revascularization drug therapy. - Women who are pregnant at the time of PET2 |
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Medical Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Ochsner Health System | Bracco Corporate |
United States,
Bober RM, Thompson CD, Morin DP. The effect of coronary revascularization on regional myocardial blood flow as assessed by stress positron emission tomography. J Nucl Cardiol. 2017 Jun;24(3):961-974. doi: 10.1007/s12350-016-0442-2. Epub 2016 Mar 28. — View Citation
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Dattilo PB, Prasad A, Honeycutt E, Wang TY, Messenger JC. Contemporary patterns of fractional flow reserve and intravascular ultrasound use among patients undergoing percutaneous coronary intervention in the United States: insights from the National Cardiovascular Data Registry. J Am Coll Cardiol. 2012 Dec 4;60(22):2337-9. doi: 10.1016/j.jacc.2012.08.990. — View Citation
De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Möbius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engström T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Jüni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum in: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Möbius-Winkler, Sven]. — View Citation
Gould KL, Johnson NP, Bateman TM, Beanlands RS, Bengel FM, Bober R, Camici PG, Cerqueira MD, Chow BJ, Di Carli MF, Dorbala S, Gewirtz H, Gropler RJ, Kaufmann PA, Knaapen P, Knuuti J, Merhige ME, Rentrop KP, Ruddy TD, Schelbert HR, Schindler TH, Schwaiger M, Sdringola S, Vitarello J, Williams KA Sr, Gordon D, Dilsizian V, Narula J. Anatomic versus physiologic assessment of coronary artery disease. Role of coronary flow reserve, fractional flow reserve, and positron emission tomography imaging in revascularization decision-making. J Am Coll Cardiol. 2013 Oct 29;62(18):1639-53. doi: 10.1016/j.jacc.2013.07.076. Epub 2013 Aug 28. Review. — View Citation
Gould KL. Does coronary flow trump coronary anatomy? JACC Cardiovasc Imaging. 2009 Aug;2(8):1009-23. doi: 10.1016/j.jcmg.2009.06.004. Review. Erratum in: JACC Cardiovasc Imaging. 2009 Sep;2(9):1146. — View Citation
Gould KL. Positron emission tomography in coronary artery disease. Curr Opin Cardiol. 2007 Sep;22(5):422-8. Review. — View Citation
Meijboom WB, Van Mieghem CA, van Pelt N, Weustink A, Pugliese F, Mollet NR, Boersma E, Regar E, van Geuns RJ, de Jaegere PJ, Serruys PW, Krestin GP, de Feyter PJ. Comprehensive assessment of coronary artery stenoses: computed tomography coronary angiography versus conventional coronary angiography and correlation with fractional flow reserve in patients with stable angina. J Am Coll Cardiol. 2008 Aug 19;52(8):636-43. doi: 10.1016/j.jacc.2008.05.024. — View Citation
Salerno M, Beller GA. Noninvasive assessment of myocardial perfusion. Circ Cardiovasc Imaging. 2009 Sep;2(5):412-24. doi: 10.1161/CIRCIMAGING.109.854893. Review. — View Citation
Sdringola S, Johnson NP, Kirkeeide RL, Cid E, Gould KL. Impact of unexpected factors on quantitative myocardial perfusion and coronary flow reserve in young, asymptomatic volunteers. JACC Cardiovasc Imaging. 2011 Apr;4(4):402-12. doi: 10.1016/j.jcmg.2011.02.008. — View Citation
Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absolute Myocardial Flow (CC/Min/GM) | Baseline absolute coronary flow and CFR will be obtained for each major coronary artery territory [left anterior descending (LAD), left circumflex (LCx), right coronary (RCA)] using FDA-approved software pre- and post-revascularization. The change in pre-vascularization and post-vascularization myocardial blood flow and relative perfusion defects will be compared | Within 12 Weeks |
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