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Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patients With Shunt or Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT02449083
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:

There is preliminary evidence that a dynamic T2 Preparations Puls sequence by cardiac magnet resonance imaging can differentiate between oxygenated and deoxygenated blood.

In adult patients with inborn heart defects this has not yet been researched. Therefore,patients with ventriculoperitoneal shunt, septal and atrio-septal shunt should be examined. Also, patients with chronic obstructive pulmonary disease should be examined.

The aim of this study is the validation of a novel magnet resonance sequence in terms of a distinction of oxygenated blood to deoxygenated blood in comparison to invasive method of measuring cardiac catheterization.


Condition or disease Intervention/treatment
Dynamic T2 Preparation Procedure: MRI Procedure: coronary angiography

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patient With Shunt or Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Arm 1
Patients with indication for MRI and coronary angiography
Procedure: MRI
MRI

Procedure: coronary angiography
coronary angiography

Arm 2
Patients with atrioseptal or ventriculoseptal Shunt with indication to coronary angiography
Procedure: MRI
MRI

Procedure: coronary angiography
coronary angiography

Arm 3
Patients with chronic obstructive pulmonary disease with indication to coronary angiography
Procedure: MRI
MRI

Procedure: coronary angiography
coronary angiography




Primary Outcome Measures :
  1. ventricular volumetry [ Time Frame: baseline ]
    ventricular volumetry by Cardiac Magnet Resonance Imaging using dynamic T2 Preparation Puls for arithmetical determination of end-systolic volume, end-diastolic volume, ejection fraction, stroke volume and myocardial weight


Secondary Outcome Measures :
  1. oxygen partial pressure [ Time Frame: baseline ]
    Determination of oxygen partial pressure (pO2) during angiography

  2. carbon dioxide partial pressure [ Time Frame: baseline ]
    Determination of carbon dioxide partial pressure (pCO2) during angiography

  3. pH-value [ Time Frame: baseline ]
    Determination of pH-value od blood during angiography

  4. Blood gas analysis [ Time Frame: baseline ]
    Determination of base excess of blood during angiography

  5. Blood gas analysis [ Time Frame: baseline ]
    Determination of oxygen partial pressure (pO2), carbon dioxide partial pressure (pCO2), pH-value, base excess

  6. Major adverse cardiac events [ Time Frame: 12 month after procedure ]
    Major adverse cardiac events: death, new indication for angiography, hospitalization


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD, who is planned for MRI and angiography
Criteria

Inclusion Criteria:

  • patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD
  • written informed consent

Exclusion Criteria:

  • patients with ST-elevation
  • contraindication for MRI
  • heavy kidney disease
  • pregnant or breast feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449083


Locations
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Germany
University Hospital Duesseldorf
Duesseldorf, Germany
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
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Principal Investigator: Britta Butzbach, MD Heinrich-Heine University, Duesseldorf

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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Dr. med. Britta Butzbach, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02449083     History of Changes
Other Study ID Numbers: 13-007
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
MRI
Shunt
COPD
Dynamic T2 Preparation Puls
new sequences
magnet resonance imaging
ventricular septal defect
Atrial septal defect
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases