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

November 19, 2015 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Cardiac Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patient With Shunt or Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Duesseldorf, Germany
        • University Hospital Duesseldorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygen partial pressure
Time Frame: baseline
Determination of oxygen partial pressure (pO2) during angiography
baseline
carbon dioxide partial pressure
Time Frame: baseline
Determination of carbon dioxide partial pressure (pCO2) during angiography
baseline
pH-value
Time Frame: baseline
Determination of pH-value od blood during angiography
baseline
Blood gas analysis
Time Frame: baseline
Determination of base excess of blood during angiography
baseline
Blood gas analysis
Time Frame: baseline
Determination of oxygen partial pressure (pO2), carbon dioxide partial pressure (pCO2), pH-value, base excess
baseline
Major adverse cardiac events
Time Frame: 12 month after procedure
Major adverse cardiac events: death, new indication for angiography, hospitalization
12 month after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Britta Butzbach, MD, Heinrich-Heine University, Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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