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
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Other: Perfusion CMR for detection of coronary artery disease
Other: Perfusion cardiac magnetic resonance imaging
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicenter, Phase III, Open-label Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Amersham Buchler, GmbH & Co KG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 533
Study Start Date: July 2003
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perfusion CMR examination
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
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00977093

Sponsors and Collaborators
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)
Investigators
Study Director: Karoline Meurer, Med Vet Amersham Buchler GmbH & Co. KG, Ismaning b. Muenchen, Germany
  More Information

No publications provided by Amersham Buchler, GmbH & Co KG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Juerg Schwitter, University Hospital Lausanne - CHUV, Switzerland
ClinicalTrials.gov Identifier: NCT00977093     History of Changes
Other Study ID Numbers: SOV 303 / SOV 304
Study First Received: September 14, 2009
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Keywords provided by Amersham Buchler, GmbH & Co KG:
Coronary artery disease
Cardiac magnetic resonance imaging
single photon emission computed tomography
invasive coronary angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Gadodiamide
Gadolinium DTPA
Gadobenic acid
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014