ClinicalTrials.gov
ClinicalTrials.gov Menu

Meta-Analysis of Stress Myocardial Perfusion Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03180060
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Lilia M. Sierra-Galan, MD, MCvT, FACC, FSCCT, American British Cowdray Medical Center

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.

Condition or disease
Coronary Disease Echocardiography Fractional Flow Reserve, Myocardial Hemodynamics Humans Magnetic Resonance Imaging Myocardial Perfusion Imaging Perfusion Predictive Value of Tests Single Photon Emission Computed Tomography Positron Emission Tomography Multidetector Computed Tomography Echocardiography, Stress Coronary Angiography

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 23051 participants
Observational Model: Other
Time Perspective: Other
Official Title: Accuracy and Heterogeneity of Stress Imaging for Detecting Coronary Artery Disease: A Systematic Review and Meta-Analysis Using HSROC Methods in 23,051 Patients.
Actual Study Start Date : August 3, 2015
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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).



Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: Period comprise between 1970 up to the end of 2015. ]
    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.


Secondary Outcome Measures :
  1. Change the current worldwide idea [ Time Frame: Period comprise between 1970 up to the end of 2015. ]
    To change the current worldwide idea that the most commonly and broadly used non-invasive imaging modalities, SPECT and Stress Echo, have the highest diagnostic accuracy for detection of coronary artery disease

  2. Modification of the concept that the newer non-invasive imaging modalities are not far more expensive than the older ones. [ Time Frame: Period comprise between 1970 up to the end of 2015. ]
    To modify the concept that the newer non-invasive imaging modalities, CMR, CTP and PET, are not far more expensive than the older ones, SPECT and Stress Echo, that some of the newer techniques could also be cheaper, and in light of their higher diagnostic accuracy, they will actually be less expensive and safer to the patient, since those exams could avoid unnecessary expensive, invasive and riskier tests to the patients and Institutions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We searched all literature in English and Spanish from January 1970 to December 2015 that meet the inclusion criteria.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180060


Locations
Mexico
American British Cowdray Medical Center
Mexico City, Mexico, 05300
Sponsors and Collaborators
American British Cowdray Medical Center
Investigators
Principal Investigator: Lilia M Sierra-Galan, MD, MCvT American British Cowdray Medical Center

Publications:
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. Erratum in: Circulation. 2014 Apr 22;129(16):e462.
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. Review.

Responsible Party: Lilia M. Sierra-Galan, MD, MCvT, FACC, FSCCT, American British Cowdray Medical Center
ClinicalTrials.gov Identifier: NCT03180060     History of Changes
Other Study ID Numbers: ABC 13-17
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are intended to publish the corresponding paper in a high-impact journal, with all information available to other researchers in the corresponding appendix.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lilia M. Sierra-Galan, MD, MCvT, FACC, FSCCT, American British Cowdray Medical Center:
Likelihood Ratio
Cardiovascular Magnetic Resonance
CMR
Myocardial Perfusion
Predictive Values
Computed Tomography Perfusion
CTP
SPECT
PET
Diagnostic Accuracy
Quantitative Coronary Angiography
Area Under the Curve
ROC Curve

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases