NCT01710254

Brief Summary

Atrial fibrillation (AF) is growing into an epidemic affecting 1 in 4 adults. There is a need for research to elucidate the prevalence of ischemic cardiomyopathy in patients diagnosed with AF. The objective of this study is to demonstrate the utility of MRI in assessment of coronary artery disease. The specific objective is to demonstrate sensitivity/specificity comparable to that reported in meta-analyses of non-AF patients and adenosine (90% /80%) in an AF population using the time-efficient vasodilator regadenoson that requires only a single intravenous (IV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 7, 2017

Completed
Last Updated

December 13, 2017

Status Verified

November 1, 2017

Enrollment Period

3.8 years

First QC Date

October 2, 2012

Results QC Date

October 11, 2017

Last Update Submit

November 17, 2017

Conditions

Atrial FibrillationCoronary Artery Disease

Keywords

MRIAtrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)

    Determination of sensitivity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.

    one MRI, up to 1 hour

  • Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)

    Determination of specificity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.

    one MRI, up to 1 hour

Secondary Outcomes (1)

  • Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)

    one MRI, up to 1 hour

Study Arms (1)

Regadenoson MRI

EXPERIMENTAL

Participants with AF receiving regadenoson stress MRI, using Gadobenate dimeglumine

Drug: Regadenoson MRIDrug: Gadobenate dimeglumine

Interventions

Regadenoson MRIDRUG

AF patients will be provided with a regadenoson stress MRI to see if coronary artery disease can be detected with more sensitivity /specificity.

Also known as: Lexiscan
Regadenoson MRI
Gadobenate dimeglumineDRUG

Resting perfusion with Multihance Gd-BOPTA contrast agent will be performed first, then a regadenoson injection will be given and MR imaging performed with a Gd-BOPTA contrast agent bolus 60-100 seconds later.

Also known as: Gd-BOPTA, Multihance
Regadenoson MRI

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed persistent or paroxysmal AF and suspected coronary artery disease who will undergo catheterization X-ray angiography

You may not qualify if:

  • Critically ill patients, patients on ventilators patients with hypotension, asthmatics, and other patients whose medical care or safety may be compromised from undergoing an MRI examination will be excluded.
  • Patients with claustrophobia will also be excluded since MRI is conducted in a closed environment.
  • Patients with contraindications to MRI (pacemaker, metal implants).
  • Pregnant subjects (or women who may become pregnant), minors, and prisoners will be excluded from this study.
  • Subjects are over 60 or have any suspicion of abnormal kidney function (a blood test to determine Glomerular filtration rate (GFR) will be performed prior to imaging. Subjects with GFR\<30 will be excluded from the study. This is standard practice for clinical scans in Radiology due to the extremely small but not negligible relationship between gadolinium contrast agent and nephrogenic systemic fibrosis in patients with severely impaired renal function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (11)

  • Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. doi: 10.1161/01.CIR.0000140263.20897.42. Epub 2004 Aug 16.

    PMID: 15313941BACKGROUND

  • Nucifora G, Schuijf JD, Tops LF, van Werkhoven JM, Kajander S, Jukema JW, Schreur JH, Heijenbrok MW, Trines SA, Gaemperli O, Turta O, Kaufmann PA, Knuuti J, Schalij MJ, Bax JJ. Prevalence of coronary artery disease assessed by multislice computed tomography coronary angiography in patients with paroxysmal or persistent atrial fibrillation. Circ Cardiovasc Imaging. 2009 Mar;2(2):100-6. doi: 10.1161/CIRCIMAGING.108.795328. Epub 2009 Jan 26.

    PMID: 19808575BACKGROUND

  • Abidov A, Hachamovitch R, Rozanski A, Hayes SW, Santos MM, Sciammarella MG, Cohen I, Gerlach J, Friedman JD, Germano G, Berman DS. Prognostic implications of atrial fibrillation in patients undergoing myocardial perfusion single-photon emission computed tomography. J Am Coll Cardiol. 2004 Sep 1;44(5):1062-70. doi: 10.1016/j.jacc.2004.05.076.

    PMID: 15337220BACKGROUND

  • Smit MD, Tio RA, Slart RH, Zijlstra F, Van Gelder IC. Myocardial perfusion imaging does not adequately assess the risk of coronary artery disease in patients with atrial fibrillation. Europace. 2010 May;12(5):643-8. doi: 10.1093/europace/eup404. Epub 2009 Dec 17.

    PMID: 20022875BACKGROUND

  • Nandalur KR, Dwamena BA, Choudhri AF, Nandalur MR, Carlos RC. Diagnostic performance of stress cardiac magnetic resonance imaging in the detection of coronary artery disease: a meta-analysis. J Am Coll Cardiol. 2007 Oct 2;50(14):1343-53. doi: 10.1016/j.jacc.2007.06.030. Epub 2007 Sep 17.

    PMID: 17903634BACKGROUND

  • Hamon M, Fau G, Nee G, Ehtisham J, Morello R, Hamon M. Meta-analysis of the diagnostic performance of stress perfusion cardiovascular magnetic resonance for detection of coronary artery disease. J Cardiovasc Magn Reson. 2010 May 19;12(1):29. doi: 10.1186/1532-429X-12-29.

    PMID: 20482819BACKGROUND

  • Ablitt NA, Gao J, Keegan J, Stegger L, Firmin DN, Yang GZ. Predictive cardiac motion modeling and correction with partial least squares regression. IEEE Trans Med Imaging. 2004 Oct;23(10):1315-24. doi: 10.1109/TMI.2004.834622.

    PMID: 15493698BACKGROUND

  • S. E. Litwin, J. Fluckiger, L. Chen, T. H. Kim, N. Pack, B. Matthews, C. McGann, R. Jiji, et al. Does fixed-dose regadenoson induce comparable myocarial perfusion reserve in patients of widely varying body size? A quantitative MRI study. American Heart Association, chicago, 2010.

    BACKGROUND

  • O. J. Booker, P. Bandettini, P. Kellman, J. Wilson, S. Leung, S. Vasu, S. Shanbhag, J. Henry, et al. Time resolved measure of coronary sinus flow following regadenoson administration. Journal of cardiovascular magnetic resonance, 13(1): O74, 2011.

    BACKGROUND

  • Harper R, Reeves B. Reporting of precision of estimates for diagnostic accuracy: a review. BMJ. 1999 May 15;318(7194):1322-3. doi: 10.1136/bmj.318.7194.1322. No abstract available.

    PMID: 10323817BACKGROUND

  • Bieging ET, Haider I, Adluru G, Chang L, Suksaranjit P, Likhite D, Shaaban A, Jensen L, Wilson BD, McGann CJ, DiBella E. Rapid rest/stress regadenoson ungated perfusion CMR for detection of coronary artery disease in patients with atrial fibrillation. Int J Cardiovasc Imaging. 2017 Nov;33(11):1781-1788. doi: 10.1007/s10554-017-1168-1. Epub 2017 May 20.

    PMID: 28528431DERIVED

MeSH Terms

Conditions

Atrial FibrillationCoronary Artery Disease

Interventions

regadenosongadobenic acid

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Edward DiBella, Ph.D.
Organization
University of Utah, Dept. of Radiology Research
edward.dibella@hsc.utah.edu
801-585-5543

Study Officials

  • Brent Wilson, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 19, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 13, 2017

Results First Posted

November 7, 2017

Record last verified: 2017-11

Locations

US(1)