Coronary Revascularization Assessed by Stress PET

NCT02931331 | Unknown

• 1 other identifier: Pro00011114
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Stenoses; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Occlusion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational

Patients undergoing standard of care (PET stress testing followed by mechanical revascularization) are undergoing an additional PET stress test to determine the impact of revascularization.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead
• Bracco Corporate: collaborator

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Related Publications (12)

• Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

  PMID: 17387127 BACKGROUND

• 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.

  PMID: 20579537 BACKGROUND

• De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni 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.

  PMID: 22924638 BACKGROUND

• 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. No abstract available.

  PMID: 23194945 BACKGROUND

• 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.

  PMID: 19679290 BACKGROUND

• White CW, Wright CB, Doty DB, Hiratza LF, Eastham CL, Harrison DG, Marcus ML. Does visual interpretation of the coronary arteriogram predict the physiologic importance of a coronary stenosis? N Engl J Med. 1984 Mar 29;310(13):819-24. doi: 10.1056/NEJM198403293101304.

  PMID: 6700670 BACKGROUND

• 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.

  PMID: 18702967 BACKGROUND

• 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.

  PMID: 27021385 BACKGROUND

• Gould KL. Positron emission tomography in coronary artery disease. Curr Opin Cardiol. 2007 Sep;22(5):422-8. doi: 10.1097/HCO.0b013e3281fc9835.

  PMID: 17762543 BACKGROUND

• 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.

  PMID: 21492816 BACKGROUND

• Gould KL, Johnson NP, Bateman TM, Beanlands RS, Bengel FM, Bober R, Camici PG, Cerqueira MD, Chow BJW, 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):1639-1653. doi: 10.1016/j.jacc.2013.07.076. Epub 2013 Aug 28.

  PMID: 23954338 BACKGROUND

• Salerno M, Beller GA. Noninvasive assessment of myocardial perfusion. Circ Cardiovasc Imaging. 2009 Sep;2(5):412-24. doi: 10.1161/CIRCIMAGING.109.854893. No abstract available.

  PMID: 19808630 BACKGROUND

MeSH Terms

Conditions

Coronary Stenosis; Myocardial Ischemia; Coronary Disease; Coronary Occlusion

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Robert Bober, M.D.

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: October 13, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)