- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00977093
A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging (MR-IMPACT-II)
A Multicenter, Phase III, Open-label Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging
The purpose of this study is to determine how well perfusion cardiac magnetic resonance (MR) imaging is able to detect certain heart abnormalities, such as a coronary artery narrowing.
To this purpose, a conventional MR contrast medium (Gd-DTPA-BMA) will be used during an adenosine infusion (an approved substance which enlarges the arteries of the heart, so that the blood flow to the heart muscle increases). This magnetic resonance imaging technique will be compared with single photon emission computed tomography (SPECT), a well-established technique to detect this heart abnormalities.
Both, cardiac MR and SPECT will be compared with invasive coronary angiography, a technique which directly visualized the heart vessels and narrowings of these (=standard of reference).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subject is a man or woman and is 18 years of age or older.
- For women of childbearing potential, the results of a urine or serum human chorionic gonadotropin (beta-HCG) pregnancy test, done at screening (with the result known before investigational product administration), must be negative. Only those women who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or postmenopausal (cessation of menses for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening.
- The subject is conscious and able to comply with study procedures.
- Written, informed consent is obtained.
- The subject is suspected, as a results of their clinical signs and symptoms, of having CAD (most subjects will probably be included using these criteria).
- The subject is referred to a quantitative CXA for known or suspected CAD or has undergone quantitative CXA within 4 weeks prior to MRI without any intervention or change of symptoms since the CXA examination.
- The subject is referred for a SPECT for a functional evaluation of myocardial perfusion or has undergone SPECT within 4 weeks prior to MRI without any intervention, or change in symptoms, between the 2 examinations (the findings of SPECT will not be taken into account for inclusion purposes).
Exclusion Criteria:
- The subject is lactating.
- The subject is pregnant as defined by a urine or serum beta-HCG pregnancy test obtained within the 24 hours before dosing.
- The subject was previously included in this study.
- The subject received an investigational product in the 30 days before or will receive one during or in the 30 days after investigational product administration.
- The subject has known allergies or a contra-indication to the investigational product.
- The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
- The subject received or is scheduled to receive an MRI contrast medium (other than the investigational product) within 24 hours prior to or in the 24 hours following the investigational product administration.
- The subject received or is scheduled to receive an X-ray contrast medium within 12 hours prior to or 12 hours following the investigational product administration.
- The subject received or is scheduled to receive a SPECT radiotracer within 24 hours prior to or 24 hours following the investigational product administration.
- The subject received or is scheduled to receive a stress examination (other than the MR stress examination in this study) within 24 hours prior to or 24 hours following the investigational product administration.
- The subject has experienced a myocardial infarction within the last 14 days.
- The subject has experienced more than 1 previous myocardial infarction.
- The subject has a bypass graft.
- The subject has second or third degree atrioventricular block, sick sinus syndrome or a symptomatic bradycardia.
- The subject suffers from asthma, bronchospasms or obstructive pulmonary disease.
- The subject has severe hypotension (<90 mm Hg systolic).
- The subject has unstable angina pectoris.
- The subject has a decompensated congestive cardiac failure.
- The subject's ECG shows a prolonged QT interval.
- The subject has a contra-indication for MRI according to clinical guidelines, local regulations or manufacturer's recommendations.
- The subject has cardiac arrhythmia considered by the investigator to be of a type or of a sufficient degree to make the subject unsuitable for the study.
- The subject has consumed coffee, tea, coke, chocolate or other caffeinated beverages in the last 24 hours before the adenosine administration.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perfusion CMR examination
All patients will undergo perfusion CMR examination, single-photon emission computed tomography, and conventional invasive coronary angiography.
|
Perfusion CMR is performed during adenosine infusion for vasodilation (3 minutes of 0.14mg/kg/min IV) and injection of Gd-DTPA-BMA at 0.075mmol/kg IV.
Other Names:
Perfusion CMR with Gd-DTPA-BMA to detect coronary artery disease
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-inferiority of perfusion CMR vs SPECT for sensitivity and specificity (binary reading) for the detection of coronary artery disease
Time Frame: SPECT and invasive angiography are performed within 4 weeks before or after CMR
|
SPECT and invasive angiography are performed within 4 weeks before or after CMR
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of the diagnostic performance of CMR and SPECT expressed as area under the receiver operator characteristics curve to detect coronary artery disease
Time Frame: SPECT and invasive angiography are performed within 4 weeks before or after CMR
|
SPECT and invasive angiography are performed within 4 weeks before or after CMR
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Karoline Meurer, Med Vet, Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Antidotes
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Pentetic Acid
Other Study ID Numbers
- SOV 303 / SOV 304
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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