Trial Outcomes & Findings for Myocardial Stress Perfusion Imaging With Dual Source CT (NCT NCT00853671)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

18 months

Results posted on

2018-12-17

Participant Flow

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

Participant milestones

Participant milestones
Measure	Myocardial Stress CT Perfusion Imaging 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)
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Myocardial Stress Perfusion Imaging With Dual Source CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Myocardial Stress CT Perfusion Imaging n=50 Participants Patients who will undergo myocardial stress CT perfusion imaging.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=93 Participants
Age, Categorical >=65 years	18 Participants n=93 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 10.4 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	41 Participants n=93 Participants
Region of Enrollment United States	50 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Myocardial Stress CT Perfusion Imaging n=50 Participants Patients who will undergo myocardial stress CT perfusion imaging.
Per-Vessel Sensitivity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.	79 percentage of participants Interval 63.0 to 90.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Myocardial Stress CT Perfusion Imaging n=50 Participants Patients who will undergo myocardial stress CT perfusion imaging.
Per-Vessel Specificity of CTP in the Detection of Myocardial Perfusion Defects During Pharmacological Stress as Compared to Invasive Angiography.	80 percentage of participants Interval 68.0 to 89.0

SECONDARY outcome

Timeframe: 18 months

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

Outcome measures

Outcome measures
Measure	Myocardial Stress CT Perfusion Imaging n=50 Participants Patients who will undergo myocardial stress CT perfusion imaging.
Per-Patient Correlation Between CTP and SPECT at Stress.	0.60 correlation coefficient

SECONDARY outcome

Timeframe: 18 months

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

Outcome measures

Outcome measures
Measure	Myocardial Stress CT Perfusion Imaging n=50 Participants Patients who will undergo myocardial stress CT perfusion imaging.
Per-Patient Correlation Between CTP and SPECT at Rest.	0.76 correlation coefficient

Adverse Events

Myocardial Stress CT Perfusion Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian B. Ghoshhajra

Massachusetts General Hospital

Phone: 617-726-3745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60