Dynamic T2 Preparation Clinical Trial
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)
| Verified date | November 2015 |
| Source | Heinrich-Heine University, Duesseldorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Duesseldorf | Duesseldorf |
| Lead Sponsor | Collaborator |
|---|---|
| Heinrich-Heine University, Duesseldorf |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ventricular volumetry | 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 | No |
| Secondary | oxygen partial pressure | Determination of oxygen partial pressure (pO2) during angiography | baseline | No |
| Secondary | carbon dioxide partial pressure | Determination of carbon dioxide partial pressure (pCO2) during angiography | baseline | No |
| Secondary | pH-value | Determination of pH-value od blood during angiography | baseline | No |
| Secondary | Blood gas analysis | Determination of base excess of blood during angiography | baseline | No |
| Secondary | Blood gas analysis | Determination of oxygen partial pressure (pO2), carbon dioxide partial pressure (pCO2), pH-value, base excess | baseline | No |
| Secondary | Major adverse cardiac events | Major adverse cardiac events: death, new indication for angiography, hospitalization | 12 month after procedure | No |