NCT03180060

Brief Summary

Background: Detection of coronary artery disease (CAD) is important due to its high prevalence and its medical and economic implications. Purpose: A systematic review of the diagnostic performance of stress echocardiography (Echo), SPECT, cardiac magnetic resonance (CMR), CT Perfusion (CTP) and PET versus invasive coronary angiography (ICA) or fractional flow reserve (FFR) using hierarchical summary ROC (HSROC) methods. Data Sources: MEDLINE, EMBASE and SCOPUS for literature published in English or Spanish from January 1970 to December 2015. Study Selection: For inclusion, studies had to meet the Cochrane guidelines, had to evaluate the sensitivity and specificity methods, and use ICA and/or FFR. Only those studies with STARD methodology ≥60% were included. Data Extraction: Ten investigators extracted patient and study characteristics and 4 resolved any disagreements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23,051

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

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

Study Start

First participant enrolled

August 3, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 6, 2017

Last Update Submit

June 6, 2017

Conditions

Keywords

Likelihood RatioCardiovascular Magnetic ResonanceCMRMyocardial PerfusionPredictive ValuesComputed Tomography PerfusionCTPSPECTPETDiagnostic AccuracyQuantitative Coronary AngiographyArea Under the CurveROC Curve

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    To introduce scientifically strong evidence-based concepts about the greater diagnostic accuracy of newer and less widely used non-invasive imaging modalities, CMR, CTP and PET, and to emphasize that some of them are even more harmless than the older and more commonly used methods such as SPECT and Stress. Echo.

    Period comprise between 1970 up to the end of 2015.

Secondary Outcomes (2)

  • Change the current worldwide idea

    Period comprise between 1970 up to the end of 2015.

  • Modification of the concept that the newer non-invasive imaging modalities are not far more expensive than the older ones.

    Period comprise between 1970 up to the end of 2015.

Study Arms (5)

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).

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).

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).

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).

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We searched all literature in English and Spanish from January 1970 to December 2015 that meet the inclusion criteria.

You may qualify if:

  • All studies (prospective, retrospective and even case series) that included patients of any age and gender with known or suspected coronary artery disease and evaluated the sensitivity and specificity of SE, SPECT, CMR, CTP and PET compared with ICA and/or FFR, and to that met the Cochrane guidelines including a score of \>60% with STARD methodology.

You may not qualify if:

  • Studies that included patients with known previous myocardial infarction, previous PCI with or without stent implantation, previous cardiac bypass surgery, heart transplantation, and the absence of invasive coronary angiography as a gold standard.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American British Cowdray Medical Center

Mexico City, 05300, Mexico

Location

Related Publications (19)

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    PMID: 25173339BACKGROUND
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    PMID: 25827388BACKGROUND
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    PMID: 22554604BACKGROUND
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  • 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.

    PMID: 22999722BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Lilia M Sierra-Galan, MD, MCvT

    American British Cowdray Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lilia M. Sierra-Galan, MD, MCvT, FACC, FSCCT

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

August 3, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

We are intended to publish the corresponding paper in a high-impact journal, with all information available to other researchers in the corresponding appendix.

Locations