Myocardial Stress Perfusion Imaging With Dual Source CT

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00853671
• Collaborator: Astellas Pharma Inc (Industry)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The investigators propose a novel technique using dual source multidetector computed tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary plaque as well as assess the functional significance of a stenosis.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: Adenosine Stress Dual-source CTP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Myocardial Stress Perfusion Imaging With Dual Source CT
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Adenosine Stress Dual-source CTP A multiphase adenosine Stress Dual-source stress perfusion computed tomography imaging test, as described above, will be performed in all patients.

Other: Adenosine Stress Dual-source CTP; 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) This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.; Other Names: Adenosine Iopamidol 370 Siemens SOMATOM Definition

Outcome Measures

Primary Outcome Measures

1. Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. [18 months]

   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.

2. Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography. [18 months]

   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.

Secondary Outcome Measures

1. Per-Patient Correlation Between CTP and SPECT at Stress. [18 months]

   Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.

2. Per-Patient Correlation Between CTP and SPECT at Rest. [18 months]

   Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A prior adenosine or exercise stress SPECT exam with high likelihood of being referred to the cardiac catheterization laboratory for invasive angiogram

• Age > 40 years old

• Able to comprehend and sign the consent form.

Exclusion Criteria:

• Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)

• Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)

• Premenopausal women who have a positive pregnancy test.

• Serum Creatinine level ≥1.5 mg/dl as an indicator of renal insufficiency.

• Known allergy to iodinated contrast agents

• Atrial fibrillation

• Asthma

• Critical aortic stenosis

• Systolic blood pressure < 90 mmHg

• Advanced heart block

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Astellas Pharma Inc

Investigators

• Principal Investigator: Brian B Ghoshhajra, MD, Massachusetts General Hospital
• Study Director: Ricardo C Cury, MD, Massachusetts General Hospital, Baptist Hospital, Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hulten EA, Bittencourt MS, Ghoshhajra B, Blankstein R. Stress CT perfusion: coupling coronary anatomy with physiology. J Nucl Cardiol. 2012 Jun;19(3):588-600. doi: 10.1007/s12350-012-9546-5. Review.
• Techasith T, Cury RC. Stress myocardial CT perfusion: an update and future perspective. JACC Cardiovasc Imaging. 2011 Aug;4(8):905-16. doi: 10.1016/j.jcmg.2011.04.017. Review.

• Responsible Party: Brian Burns Ghoshhajra, Clinical Director, Cardiac CT and MRI, Department of Radiology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00853671
• Other Study ID Numbers: DSCTSTRESS
• First Posted: Mar 2, 2009
• Last Update Posted: Dec 17, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Brian Burns Ghoshhajra, Clinical Director, Cardiac CT and MRI, Department of Radiology, Massachusetts General Hospital: Coronary Artery Disease; Multidetector Computed Tomography; Myocardial Perfusion Imaging
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Adenosine

Study Results

Participant Flow

Recruitment Details	Recruitment Period: 3/3/2008 - 7/1/2009

Arm/Group Title	Myocardial Stress CT Perfusion Imaging
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

Baseline Characteristics

Arm/Group Title	Myocardial Stress CT Perfusion Imaging
Arm/Group Description	Patients who will undergo myocardial stress CT perfusion imaging.
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	32 64%
>=65 years	18 36%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (10.4)
Sex: Female, Male (Count of Participants)
Female	9 18%
Male	41 82%
Region of Enrollment (participants) [Number]
United States	50 100%

Outcome Measures

1. Primary Outcome

Title	Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myocardial Stress CT Perfusion Imaging
Arm/Group Description	Patients who will undergo myocardial stress CT perfusion imaging.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	79 158%

2. Secondary Outcome

Title	Per-Patient Correlation Between CTP and SPECT at Stress.
Description	Pearson Correlation between research interpretation of CTP images and SPECT images, both performed during stress.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myocardial Stress CT Perfusion Imaging
Arm/Group Description	Patients who will undergo myocardial stress CT perfusion imaging.
Measure Participants	50
Number [correlation coefficient]	0.60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Myocardial Stress CT Perfusion Imaging
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Pearson Correlation
	Comments

3. Primary Outcome

Title	Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myocardial Stress CT Perfusion Imaging
Arm/Group Description	Patients who will undergo myocardial stress CT perfusion imaging.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	80 160%

4. Secondary Outcome

Title	Per-Patient Correlation Between CTP and SPECT at Rest.
Description	Pearson Correlation performed on myocardial abnormalities on CTP and SPECT images, obtained at rest.
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Myocardial Stress CT Perfusion Imaging
Arm/Group Description	Patients who will undergo myocardial stress CT perfusion imaging.
Measure Participants	50
Number [correlation coefficient]	0.76

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
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Pearson Correlation
	Comments

Adverse Events

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
Arm/Group Description	Patients who will undergo myocardial stress CT perfusion imaging.
All Cause Mortality
	Myocardial Stress CT Perfusion Imaging
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Myocardial Stress CT Perfusion Imaging
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Myocardial Stress CT Perfusion Imaging
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

Single-Center Study, Referral Population

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.