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Completed

NCT Number: NCT02449083

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

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.

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Key information

Conditions

Dynamic T2 Preparation Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Heart Septal Defects, Ventricular Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Duesseldorf

Düsseldorf, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

MRI

Coronary Angiography

Procedure

coronary angiography

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 20, 2015
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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