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Trial record 76 of 1193 for:    Adenosine

Myocardial Stress Perfusion Imaging With Dual Source CT

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: NCT00853671
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Brian Burns Ghoshhajra, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Intervention Other: Adenosine Stress Dual-source CTP
Enrollment 50
Recruitment Details Recruitment Period: 3/3/2008 - 7/1/2009
Pre-assignment Details  
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description Patients who will undergo myocardial stress CT perfusion imaging. Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)
Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description Patients who will undergo myocardial stress CT perfusion imaging.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
  64.0%
>=65 years
18
  36.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
62.3  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
9
  18.0%
Male
41
  82.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Hide Description The gold standard for abnormality by CTP is defined as a focal stenosis of >50% at quantitative analysis of invasive coronary angiography images, when performed.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description:
Patients who will undergo myocardial stress CT perfusion imaging.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
79
(63 to 90)
2.Primary Outcome
Title Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
Hide Description The gold standard for abnormality by CTP is defined as stenosis of 50% or more at quantitative analysis of invasive coronary angiography images, when performed.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description:
Patients who will undergo myocardial stress CT perfusion imaging.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80
(68 to 89)
3.Secondary Outcome
Title Per-Patient Correlation Between CTP and SPECT at Stress.
Hide Description Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description:
Patients who will undergo myocardial stress CT perfusion imaging.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: correlation coefficient
0.60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myocardial Stress CT Perfusion Imaging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pearson Correlation
Comments [Not Specified]
4.Secondary Outcome
Title Per-Patient Correlation Between CTP and SPECT at Rest.
Hide Description Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description:
Patients who will undergo myocardial stress CT perfusion imaging.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: correlation coefficient
0.76
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myocardial Stress CT Perfusion Imaging
Comments Pearson Correlation
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Pearson Correlation
Comments [Not Specified]
Time Frame 1 day
Adverse Event Reporting Description To assure subject’s safety, the study physician will monitor the safety of the subject. Heart rate and blood pressure will be measured immediately prior and 2 and 5 minutes after the administration of adenosine. ECG and heart rate will be continuously monitored during scanning. If adverse events occur the exam will immediately be stopped.
 
Arm/Group Title Myocardial Stress CT Perfusion Imaging
Hide Arm/Group Description Patients who will undergo myocardial stress CT perfusion imaging.
All-Cause Mortality
Myocardial Stress CT Perfusion Imaging
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Myocardial Stress CT Perfusion Imaging
Affected / at Risk (%)
Total   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Myocardial Stress CT Perfusion Imaging
Affected / at Risk (%)
Total   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brian B. Ghoshhajra
Organization: Massachusetts General Hospital
Phone: 617-726-3745
EMail: bghoshhajra@partners.org
Publications of Results:
Layout table for additonal information
Responsible Party: Brian Burns Ghoshhajra, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00853671     History of Changes
Other Study ID Numbers: DSCTSTRESS
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: May 18, 2010
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018