A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging (MR-IMPACT-II)

This study has been completed.
Sponsor:
Collaborators:
Beacon Bioscience, Inc.
Cleveland Clinic Foundation, Cleveland, USA (Corelab for coronary angiography analysis)
CRL, Medinet Europe, Breda, The Netherlands (Corelab for blood sample analyses)
Biomedical Systems (BMS) Europe, Brussels, Belgium (Corelab for ECG analysis)
Information provided by:
Amersham Buchler, GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00977093
First received: September 14, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted

September 14, 2009
September 14, 2009
July 2003
June 2004   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging
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).

This study is a multicentre, open label, phase III study in adult subjects designed to show that Gd-DTPA-BMA (a conventional MR contrast medium = OMNISCAN) enhanced myocardial MR perfusion imaging is non-inferior to myocardial SPECT. Both imaging techniques will be performed during adenosine stress (0.14mg/min/kg over 3 minutes IV). Gd-DTPA-BMA will be used twice (2 doses of 0.075 mmol/kg for the stress and rest study each) for the detection of myocardial perfusion defects. The standard of reference is invasive coronary angiography, which defines the presence of coronary artery disease, if vessels of at least 2mm in diameter show stenosis of at least 50% (diameter reduction). Patients with a history of myocardial infarction(s) are positive for coronary artery disease, even when coronary arteries are not stenosed as evidenced by the coronary angiography performed in the setting of this trial(= assigning patients as positive for coronary artery disease after successful PCI-revascularization of acute infarct(s) in the past).

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Other: Perfusion CMR for detection of coronary artery disease
    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 Name: MR contrast medium: Gd-DTPA-BMA is Omniscan
  • Other: Perfusion cardiac magnetic resonance imaging
    Perfusion CMR with Gd-DTPA-BMA to detect coronary artery disease
    Other Name: Conventional MR contast medium: Gd-DTPA-BMA is Omniscan
Experimental: Perfusion CMR examination
All patients will undergo perfusion CMR examination, single-photon emission computed tomography, and conventional invasive coronary angiography.
Interventions:
  • Other: Perfusion CMR for detection of coronary artery disease
  • Other: Perfusion cardiac magnetic resonance imaging
Schwitter J, Wacker CM, Wilke N, Al-Saadi N, Sauer E, Huettle K, Schönberg 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;14:61.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
533
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The subject is a man or woman and is 18 years of age or older.
  2. 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.
  3. The subject is conscious and able to comply with study procedures.
  4. Written, informed consent is obtained.
  5. 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).
  6. 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.
  7. 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:

  1. The subject is lactating.
  2. The subject is pregnant as defined by a urine or serum beta-HCG pregnancy test obtained within the 24 hours before dosing.
  3. The subject was previously included in this study.
  4. 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.
  5. The subject has known allergies or a contra-indication to the investigational product.
  6. The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
  7. 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.
  8. 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.
  9. The subject received or is scheduled to receive a SPECT radiotracer within 24 hours prior to or 24 hours following the investigational product administration.
  10. 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.
  11. The subject has experienced a myocardial infarction within the last 14 days.
  12. The subject has experienced more than 1 previous myocardial infarction.
  13. The subject has a bypass graft.
  14. The subject has second or third degree atrioventricular block, sick sinus syndrome or a symptomatic bradycardia.
  15. The subject suffers from asthma, bronchospasms or obstructive pulmonary disease.
  16. The subject has severe hypotension (<90 mm Hg systolic).
  17. The subject has unstable angina pectoris.
  18. The subject has a decompensated congestive cardiac failure.
  19. The subject's ECG shows a prolonged QT interval.
  20. The subject has a contra-indication for MRI according to clinical guidelines, local regulations or manufacturer's recommendations.
  21. 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.
  22. The subject has consumed coffee, tea, coke, chocolate or other caffeinated beverages in the last 24 hours before the adenosine administration.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00977093
SOV 303 / SOV 304
No
Prof. Juerg Schwitter, University Hospital Lausanne - CHUV, Switzerland
Amersham Buchler, GmbH & Co KG
  • Beacon Bioscience, Inc.
  • Cleveland Clinic Foundation, Cleveland, USA (Corelab for coronary angiography analysis)
  • CRL, Medinet Europe, Breda, The Netherlands (Corelab for blood sample analyses)
  • Biomedical Systems (BMS) Europe, Brussels, Belgium (Corelab for ECG analysis)
Study Director: Karoline Meurer, Med Vet Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany
Amersham Buchler, GmbH & Co KG
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP