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Coronary Artery DiseasePhase 3MR-IMPACT-IINCT00977093

A Study of Gadodiamide Injection in Myocardial Perfusion Magnetic Resonance Imaging

A Phase 3 study testing Perfusion CMR for detection of coronary artery disease and Perfusion cardiac magnetic resonance imaging in people with Coronary Artery Disease, run by Amersham Buchler, GmbH & Co KG.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Perfusion CMR for detection of coronary artery disease and Perfusion cardiac magnetic resonance imaging
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
533 participants
Where
No sites listed yet
Study dates
Jul 2003to Jun 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

About this study

Official title: 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).

Read the 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).

Being tested
Perfusion CMR for detection of coronary artery disease, Perfusion cardiac magnetic resonance imaging
Keywords
Coronary artery disease, Cardiac magnetic resonance imaging, single photon emission computed tomography, invasive coronary angiography
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perfusion CMR for detection of coronary artery diseaseOther

    Also called MR contrast medium: Gd-DTPA-BMA is Omniscan

    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.

  • Perfusion cardiac magnetic resonance imagingOther

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

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

Study groups in NCT00977093
Study groupRoleWhat they receive
Perfusion CMR examinationExperimentalAll patients will undergo perfusion CMR examination, single-photon emission computed tomography, and conventional invasive coronary angiography.
Receives: Other: Perfusion CMR for detection of coronary artery disease; Other: Perfusion cardiac magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (1)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2009 (estimated)
  2. Study startJul 2003
  3. Primary completionJun 2004
  4. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00977093
Sponsor's protocol ID
SOV 303 / SOV 304
Acronym
MR-IMPACT-II
Status last verified
Sep 2009
First submitted
14 Sep 2009
Last updated
15 Sep 2009
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22938651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Perfusion CMR for detection of coronary artery disease and Perfusion cardiac magnetic resonance imaging in people with Coronary Artery Disease, run by Amersham Buchler, GmbH & Co KG.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00977093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.

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