Phase 4 N=697 Diagnostic

Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease

Ischemic Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00979199 ↗

Enrolled (actual)

697

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement — 140 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Non invasive cardiac imaging (Other)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement	140	—
SECONDARY Cost-benefit and Cost-effectiveness Analysis	—	—

Summary

Main purpose of the study: To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).

Eligibility Criteria

Inclusion Criteria

Patients with intermediate (>20%, 75 yrs
Pregnancy (suspected or ascertained)
LV Dysfunction (LVEF =90%) probability of CAD
Acute Coronary Syndrome
Prolonged (> 20 minutes) chest pain
De novo or accelerated angina
Hemodynamic or electrical instability
Recent ST-T segment or T wave changes of ischemic nature
Acute myocardial infarction with or without ST segment elevation
Elevated serum cardiac markers of necrosis
Known diagnosis of CAD
Previously known myocardial infarction
Previous PCI
Previous CABG
Persistent atrial fibrillation or advanced AV Block
Asthma or chronic treatment with aminophylline
Recent (<6 months) cerebral ischemic attack
Known significant carotid stenosis or vascular aneurisms
Asthma or chronic treatment with aminophylline
Active cancer
Severe hypertension. Patients cannot withdraw therapy for 12 hours.
Congenital heart disease
Significant valvular disease
Cardiomyopathy (e.g. DCM, HCM, ARVC, Amyloidosis)
Inability to provide an informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00979199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.