Myocardial Perfusion MRI

NCT01490294 | Completed Phase 2 Results

• 3 other identifiers: 910543055012005-005158-32
• Study Type: interventional
• Target: 232
• Locations: 4 countries
• Sites: 14

Brief Summary

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality. For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min. The total imaging time is about 45 min.

Conditions

Myocardial Perfusion Imaging; Magnetic Resonance Imaging

Keywords

Cardiac MRI; gadobutrol

Outcome Measures

Primary Outcomes (2)

• Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions

  Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent \[LAD\], left circumflex \[LCX\], right coronary artery \[RCA\]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

• Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments

  Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

Secondary Outcomes (55)

• Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

• Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

• Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

• Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

• Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions

  Immediately within approximately 5 seconds after Gadobutrol bolus administration

Study Arms (4)

Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)

EXPERIMENTAL

Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)

EXPERIMENTAL

Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)

EXPERIMENTAL

Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)

EXPERIMENTAL

Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.

Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadavist,Gadovist, BAY86-4875) DRUG

0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg)

Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)

Eligibility Criteria

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

You may qualify if:

• Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
• The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

You may not qualify if:

• Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
• Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
• Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
• Non-sinus rhythm
• Sinus node disease or symptomatic bradycardia
• Second or third degree atrial ventricular (AV) block
• Complete left bundle branch block (LBBB)
• Known congenital long QT syndrome or a family history of congenital long QT syndrome
• Known previous arrhythmias on drugs that prolong cardiac repolarization
• Uncorrected hypokalemia
• Uncontrolled hypertension (e.g. systolic blood pressure \>185 mm Hg, diastolic blood pressure \>110 mm Hg)
• Baseline hypotension (e.g. mean arterial pressure \<60 mm Hg)
• Ejection fraction below 35%
• Cardiomyopathy, congenital heart defect or higher degree valvular pathology
• Coronary artery stent placement within 4 weeks prior to the MRI procedure

Sponsors & Collaborators

• Bayer: lead

Study Sites (14)

Unknown Facility

Pölten, 3100, Austria

Location

Unknown Facility

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Unknown Facility

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Unknown Facility

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Unknown Facility

München, Bavaria, 81377, Germany

Location

Unknown Facility

München, Bavaria, 81675, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60389, Germany

Location

Unknown Facility

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Unknown Facility

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Unknown Facility

Essen, North Rhine-Westphalia, 45138, Germany

Location

Unknown Facility

Berlin, 10115, Germany

Location

Unknown Facility

Krakow, 31202, Poland

Location

Unknown Facility

Basel, Canton of Basel-City, 4031, Switzerland

Location

Unknown Facility

Lugano, Canton Ticino, CH-6900, Switzerland

Location

MeSH Terms

Interventions

gadobutrol

Limitations and Caveats

Study designed for perfusion imaging, not optimized for delayed enhancement. Routine SPECT selected as standard of reference (SoR) despite known quality limitations.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: December 12, 2011
• Study Start: March 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: May 22, 2014
• Results First Posted: June 28, 2012

Record last verified: 2014-05

Locations

PL (1); DE (10); AU (1); CH (2)