Trial Outcomes & Findings for Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease (NCT NCT00979199)

Last Updated: 2014-07-21

Results Overview

The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

697 participants

Primary outcome timeframe

3 months from enrollment

Results posted on

2014-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	CTCA and PET or SPECT and ECHO or MRI
Overall Study STARTED	697
Overall Study COMPLETED	475
Overall Study NOT COMPLETED	222

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CTCA and PET or SPECT and ECHO or MRI n=475 Participants
Age, Continuous	60 years STANDARD_DEVIATION 9 • n=5 Participants
Sex/Gender, Customized Male	291 participants n=5 Participants
Sex/Gender, Customized Female	184 participants n=5 Participants
Region of Enrollment France	28 participants n=5 Participants
Region of Enrollment Finland	71 participants n=5 Participants
Region of Enrollment Poland	36 participants n=5 Participants
Region of Enrollment Spain	61 participants n=5 Participants
Region of Enrollment Germany	35 participants n=5 Participants
Region of Enrollment United Kingdom	27 participants n=5 Participants
Region of Enrollment Switzerland	67 participants n=5 Participants
Region of Enrollment Italy	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months from enrollment

The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions).

Outcome measures

Outcome measures
Measure	Non Invasive Cardiac Imaging n=475 Participants All patients are submitted to non invasive cardiac imaging. 'Anatomical' information provided by CTA is obtained in every patient together with the 'functional' information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. All patients with at least one positive functional test undergo invasive coronary angiography to obtain the final diagnosis of IHD (Outcome measurement).
Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement	140 participants

SECONDARY outcome

Timeframe: 3 months

Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point.

Outcome measures

Outcome data not reported

Adverse Events

Non Invasive Cardiac Imaging

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Non Invasive Cardiac Imaging n=475 participants at risk
Cardiac disorders Severe chest pain	1.1% 5/475

Additional Information

Dr. Danilo Neglia

CNR Institute of Clinical Physiology, Pisa, Italy and Fondazione Toscana G. Monasterio, Pisa, Italy

Phone: +390503152019

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place