Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
23051 participants
OBSERVATIONAL
2015-08-03
2016-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis
NCT03976921
Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia
NCT02810795
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
NCT06030596
Stress Multidetector Computed Tomography (MDCT) an New Diagnostic Tool for Myocardial Disease
NCT00949520
Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
NCT00352937
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Searches: Search in MEDLINE, EMBASE and SCOPUS databases for the literature published in English or Spanish from January 1970 to December 2015 of all prospective and retrospective studies performed with Stress Echo, SPECT, PET, CMR and CTP in patients with suspicion or known CAD compared against the reference standard of ICA (two cutoffs: lesions \>50% and \>70%) and/or invasive FFR (two cutoffs: \<0.80 and \<0.75).
Condition being studied: Obstructive coronary artery disease. Non-invasive imaging modalities (SPECT, Stress Echo, CMR, CTP and PET) to evaluate myocardial perfusion as indicative of obstructive coronary artery disease.
Intervention: There was no intervention or exposure, since it was an evaluation of diagnostic accuracy of worldwide current non-invasive cardiovascular imaging modalities compared to the accepted standard of reference.
Comparator: No control group used.
Context: Studies in English and Spanish were included to avoid missing any relevant, high quality contributions in different languages. Other languages different from English and Spanish were not included due to language barriers and limitations regarding understanding the full text document and to obtaining the necessary data, since those papers generally only have the abstract in English. There were no restrictions in country of origin, type of technique or equipment used, since we made performed a sub-analysis for those minor variables not reported in all papers.
Data extraction: After study planning, we decided to decided to included all published studies and decided not to include data that hadn't been formally published. Our search strategy with three terms related to the research question considering: patient population, intervention types of the different imaging modalities and the design type; we decided to include two types of search terms, free words and standardized words such as those use in Medical Subject Headings (MeSH) for PubMed and for EMBASE we used EMTREE terms; we also used a combination of thematic terms selected by a controlled vocabulary, the Thesaurus, open when necessary and with broad range of free text terms. As we described in detail as follows, the data extraction was always with more than two researchers. The team was divided into a searcher, a search advisor, and five junior and four senior reviewers. Four senior reviewers gathered together to define the MeSH terms necessary for the literature search. The searcher and the search advisor (one senior reviewer) worked together to build up the corresponding search algorithms as follows: for prospective or retrospective clinical trials, case series, abstracts and gray literature in English or Spanish for PubMed, for EMBASE, and for Scopus; also for meta-analysis and systemic reviews for PubMed, for EMBASE and for Scopus for the period comprised between January 1970 to December 2015. One senior author (first author) was designed as "administrator", then all retrievals from the searcher went directly and only to the administrator to avoid duplications or gaps in the review process. First the administrator received a search with titles and abstracts, which s/he distributed equally to the four senior reviewers (including the administrator) to make an initial selection and to eliminate all titles and abstracts that did not meet the inclusion or exclusion criteria, which was then gathered together by the administrator and sent back to the searcher, whose used the list of selected documents (titles and abstracts) to send a second package of searches to the administrator with all documents in full text version, who again equally distributed these documents to all four senior reviewers, who then validated the inclusion and exclusion criteria, which may have been missed in the abstract alone; the resulting package was again returned to the administrator who equally distributed the documents to all junior and senior reviewers to score each study according to the STARD checklist for this type of project. We previously established a minimum of 60% of points in the STARD checklist for a study to be approved and be included in the next stage of the review. All scoring sheets were sent back to the administrator within the timeline period. All disagreements were solved during our research meetings by a consensus of the senior reviewers. The administrator then selected the studies to be included in the meta-analysis based on the STARD score and distributed them equally to all junior and senior reviewers (including the administrator) to extract data in a pre- designed data capture sheet. At the deadline, the administrator gathered together all data capture sheets and then re-distributed equally with the original papers to the four senior reviewers who did a second review of each study to assure quality of the extracted data. All disagreements were solved during extra research meetings of the senior reviewers by consensus. After the data were accepted by the four senior reviewers, the administrator provided another senior reviewer, acting as a "statistician" with all captured data to start the statistical analysis. At the same time, all studies included in the meta-analysis were again distributed by the administrator to two senior reviewers (the administrator and the statistician) who did the data extraction for the sub-analysis, each senior reviewer took two imaging modalities for review, and after completion those sub-analysis data were gather together by the statistician to be included in the meta-analysis.
Risk of bias: In the selection process bias risk was managed by using a double check of the selection criteria by senior reviewers, by scoring each study by STARD methodology using its checklist and a rigid criteria of \>60% to be considered for further analysis, any disagreements between the junior and/ senior review authors over the risk of bias in particular studies were solved by discussion during an extra research meeting of two senior authors, with involvement of a third reviewer when necessary. The publication bias was evaluated in graphic manner using Funnel plots and in mathematical form with Begg and Egger tests. A value of p\<0.05 was defined as significant.
Strategy for data synthesis: We performed Forrest plots for each test and HSROC curves with the Moses-Littenberg method. We calculated AUC and Q\* for each test. Total values of sensitivity, specificity, DOR, LR+ and LR-, as well as 95% CI were calculated using the bivariate model of Teitsma and the models of HSROC (hierarchical summary ROC) of Rutter and Gatsonis. The differences between the tests were evaluated using meta-regression comparing different models with the likelihood ratio test. The analysis of heterogeneity between studies was evaluated in graphic form in the HSROC curves, and in mathematical manner with meta-regression and the calculation of Higgins' I2; this last test, Higgins' I2, was not reported within the results, since in diagnostic test accuracy studies, this I2 statistic alone may not be informative as they do not consider threshold effect; in comparison to this same statistical test when it is used for the analysis of heterogeneity between therapeutic and or interventional studies, since a threshold effect can be considered. In our study the publication bias was evaluated in graphic manner using Funnel plots and in mathematical form with Begg and Egger tests. A value of p\<0.05 was defined as significant.
Analysis of subgroups: To analyze statistical differences in diagnostic accuracy between modalities, we based the analyses on mathematical combinations and used the term "certainty" to refer to diagnostic accuracy that one imaging modality has over the other one; then we performed the meta-regression analysis for comparison of "certainty" between two imaging modalities at the same time. We used a graphic representation for the results. We did a post-hoc analysis by sub-groups to all other variables, common to every technique and/or specific for each imaging modality studied.
Dissemination plans: A paper will be submitted to a leading journal in this field. The findings of the review produced solid evidence that can change current worldwide practice for the benefit of patients, institutions and public health services by obtaining higher accuracy in the diagnosis of significant coronary artery disease in terms of myocardial ischemia, thus avoiding extra unnecessary tests, less harm to the patients and less unnecessary expenses.
Current review status: Completed but not published.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPECT
SPECT compared versus four reference standards (two anatomic cutoffs: angiographic lesions \>50% and \>70% and two functional cutoffs: FFRi \<0.80 and \<0.75).
No interventions assigned to this group
Stress Echo
Stress Echo compared versus four reference standards (two anatomic cutoffs: angiographic lesions \>50% and \>70% and two functional cutoffs: FFRi \<0.80 and \<0.75).
No interventions assigned to this group
CMR perfusion
CMR perfusion compared versus four reference standards (two anatomic cutoffs: angiographic lesions \>50% and \>70% and two functional cutoffs: FFRi \<0.80 and \<0.75).
No interventions assigned to this group
CT perfusion
CT perfusion compared versus four reference standards (two anatomic cutoffs: angiographic lesions \>50% and \>70% and two functional cutoffs: FFRi \<0.80 and \<0.75).
No interventions assigned to this group
Positron Emission Tomography
PET compared versus four reference standards (two anatomic cutoffs: angiographic lesions \>50% and \>70% and two functional cutoffs: FFRi \<0.80 and \<0.75).
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
American British Cowdray Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lilia M. Sierra-Galan, MD, MCvT, FACC, FSCCT
Lilia M. Sierra-Galan, MD, MCvT, FACC, FSCCT
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lilia M Sierra-Galan, MD, MCvT
Role: PRINCIPAL_INVESTIGATOR
American British Cowdray Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
American British Cowdray Medical Center
Mexico City, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997 May 17;349(9063):1436-42. doi: 10.1016/S0140-6736(96)07495-8.
Kreatsoulas C, Anand SS. The impact of social determinants on cardiovascular disease. Can J Cardiol. 2010 Aug-Sep;26 Suppl C(Suppl C):8C-13C. doi: 10.1016/s0828-282x(10)71075-8.
Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
Lee J, Kim KW, Choi SH, Huh J, Park SH. Systematic Review and Meta-Analysis of Studies Evaluating Diagnostic Test Accuracy: A Practical Review for Clinical Researchers-Part II. Statistical Methods of Meta-Analysis. Korean J Radiol. 2015 Nov-Dec;16(6):1188-96. doi: 10.3348/kjr.2015.16.6.1188. Epub 2015 Oct 26.
McGee S. Simplifying likelihood ratios. J Gen Intern Med. 2002 Aug;17(8):646-9. doi: 10.1046/j.1525-1497.2002.10750.x.
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.
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.
Johnson NP, Toth GG, Lai D, Zhu H, Acar G, Agostoni P, Appelman Y, Arslan F, Barbato E, Chen SL, Di Serafino L, Dominguez-Franco AJ, Dupouy P, Esen AM, Esen OB, Hamilos M, Iwasaki K, Jensen LO, Jimenez-Navarro MF, Katritsis DG, Kocaman SA, Koo BK, Lopez-Palop R, Lorin JD, Miller LH, Muller O, Nam CW, Oud N, Puymirat E, Rieber J, Rioufol G, Rodes-Cabau J, Sedlis SP, Takeishi Y, Tonino PA, Van Belle E, Verna E, Werner GS, Fearon WF, Pijls NH, De Bruyne B, Gould KL. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014 Oct 21;64(16):1641-54. doi: 10.1016/j.jacc.2014.07.973.
Takx RA, Blomberg BA, El Aidi H, Habets J, de Jong PA, Nagel E, Hoffmann U, Leiner T. Diagnostic accuracy of stress myocardial perfusion imaging compared to invasive coronary angiography with fractional flow reserve meta-analysis. Circ Cardiovasc Imaging. 2015 Jan;8(1):e002666. doi: 10.1161/CIRCIMAGING.114.002666.
Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
Fihn SD, Gardin JM, Abrams J, Berra K, Blankenship JC, Dallas AP, Douglas PS, Foody JM, Gerber TC, Hinderliter AL, King SB 3rd, Kligfield PD, Krumholz HM, Kwong RY, Lim MJ, Linderbaum JA, Mack MJ, Munger MA, Prager RL, Sabik JF, Shaw LJ, Sikkema JD, Smith CR Jr, Smith SC Jr, Spertus JA, Williams SV; American College of Cardiology Foundation. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: executive summary: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012 Dec 18;126(25):3097-137. doi: 10.1161/CIR.0b013e3182776f83. Epub 2012 Nov 19. No abstract available.
Fihn SD, Blankenship JC, Alexander KP, Bittl JA, Byrne JG, Fletcher BJ, Fonarow GC, Lange RA, Levine GN, Maddox TM, Naidu SS, Ohman EM, Smith PK, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK; American College of Cardiology/Americal Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Preventive Cardiovascular Nurses Association; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons. 2014 ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Thorac Cardiovasc Surg. 2015 Mar;149(3):e5-23. doi: 10.1016/j.jtcvs.2014.11.002. Epub 2014 Nov 7. No abstract available.
Jaarsma C, Leiner T, Bekkers SC, Crijns HJ, Wildberger JE, Nagel E, Nelemans PJ, Schalla S. Diagnostic performance of noninvasive myocardial perfusion imaging using single-photon emission computed tomography, cardiac magnetic resonance, and positron emission tomography imaging for the detection of obstructive coronary artery disease: a meta-analysis. J Am Coll Cardiol. 2012 May 8;59(19):1719-28. doi: 10.1016/j.jacc.2011.12.040.
Danad I, Szymonifka J, Twisk JWR, Norgaard BL, Zarins CK, Knaapen P, Min JK. Diagnostic performance of cardiac imaging methods to diagnose ischaemia-causing coronary artery disease when directly compared with fractional flow reserve as a reference standard: a meta-analysis. Eur Heart J. 2017 Apr 1;38(13):991-998. doi: 10.1093/eurheartj/ehw095.
Greenwood JP, Ripley DP, Berry C, McCann GP, Plein S, Bucciarelli-Ducci C, Dall'Armellina E, Prasad A, Bijsterveld P, Foley JR, Mangion K, Sculpher M, Walker S, Everett CC, Cairns DA, Sharples LD, Brown JM; CE-MARC 2 Investigators. Effect of Care Guided by Cardiovascular Magnetic Resonance, Myocardial Perfusion Scintigraphy, or NICE Guidelines on Subsequent Unnecessary Angiography Rates: The CE-MARC 2 Randomized Clinical Trial. JAMA. 2016 Sep 13;316(10):1051-60. doi: 10.1001/jama.2016.12680.
Gerber TC, Carr JJ, Arai AE, Dixon RL, Ferrari VA, Gomes AS, Heller GV, McCollough CH, McNitt-Gray MF, Mettler FA, Mieres JH, Morin RL, Yester MV. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009 Feb 24;119(7):1056-65. doi: 10.1161/CIRCULATIONAHA.108.191650. Epub 2009 Feb 2. No abstract available.
Rybicki FJ, Mather RT, Kumamaru KK, Brinker J, Chen MY, Cox C, Matheson MB, Dewey M, DiCarli MF, Miller JM, Geleijns J, George RT, Paul N, Texter J, Vavere A, Yaw TS, Lima JA, Clouse ME. Comprehensive assessment of radiation dose estimates for the CORE320 study. AJR Am J Roentgenol. 2015 Jan;204(1):W27-36. doi: 10.2214/AJR.13.12375.
Ziadi MC, Dekemp RA, Williams K, Guo A, Renaud JM, Chow BJ, Klein R, Ruddy TD, Aung M, Garrard L, Beanlands RS. Does quantification of myocardial flow reserve using rubidium-82 positron emission tomography facilitate detection of multivessel coronary artery disease? J Nucl Cardiol. 2012 Aug;19(4):670-80. doi: 10.1007/s12350-011-9506-5. Epub 2012 Mar 14.
Morton G, Chiribiri A, Ishida M, Hussain ST, Schuster A, Indermuehle A, Perera D, Knuuti J, Baker S, Hedstrom E, Schleyer P, O'Doherty M, Barrington S, Nagel E. Quantification of absolute myocardial perfusion in patients with coronary artery disease: comparison between cardiovascular magnetic resonance and positron emission tomography. J Am Coll Cardiol. 2012 Oct 16;60(16):1546-55. doi: 10.1016/j.jacc.2012.05.052. Epub 2012 Sep 19.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABC 13-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.