A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging

NCT00977093 | Completed Phase 3

• 1 other identifier: SOV 303 / SOV 304
• Study Type: interventional
• Target: 533
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Cardiac magnetic resonance imaging; single photon emission computed tomography; invasive coronary angiography

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of perfusion CMR vs SPECT for sensitivity and specificity (binary reading) for the detection of coronary artery disease

  SPECT and invasive angiography are performed within 4 weeks before or after CMR

Secondary Outcomes (1)

• Assessment of the diagnostic performance of CMR and SPECT expressed as area under the receiver operator characteristics curve to detect coronary artery disease

  SPECT and invasive angiography are performed within 4 weeks before or after CMR

Study Arms (1)

Perfusion CMR examination

EXPERIMENTAL

All patients will undergo perfusion CMR examination, single-photon emission computed tomography, and conventional invasive coronary angiography.

Other: Perfusion CMR for detection of coronary artery disease; Other: Perfusion cardiac magnetic resonance imaging

Interventions

Perfusion CMR for detection of coronary artery disease OTHER

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.

Also known as: MR contrast medium: Gd-DTPA-BMA is Omniscan

Perfusion CMR examination

Perfusion cardiac magnetic resonance imaging OTHER

Perfusion CMR with Gd-DTPA-BMA to detect coronary artery disease

Also known as: Conventional MR contast medium: Gd-DTPA-BMA is Omniscan

Perfusion CMR examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amersham Buchler, GmbH & Co KG: lead
• Beacon Bioscience, Inc.: collaborator
• The Cleveland Clinic: collaborator
• CRL, Medinet Europe, Breda, The Netherlands (Corelab for blood sample analyses): collaborator
• Biomedical Systems: collaborator

Related Publications (1)

• Schwitter J, Wacker CM, Wilke N, Al-Saadi N, Sauer E, Huettle K, Schonberg SO, Debl K, Strohm O, Ahlstrom H, Dill T, Hoebel N, Simor T; MR-IMPACT investigators. Superior diagnostic performance of perfusion-cardiovascular magnetic resonance versus SPECT to detect coronary artery disease: The secondary endpoints of the multicenter multivendor MR-IMPACT II (Magnetic Resonance Imaging for Myocardial Perfusion Assessment in Coronary Artery Disease Trial). J Cardiovasc Magn Reson. 2012 Sep 2;14(1):61. doi: 10.1186/1532-429X-14-61.

  PMID: 22938651 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Karoline Meurer, Med Vet

  Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2009
• First Posted: September 15, 2009
• Study Start: July 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: September 15, 2009

Record last verified: 2009-09