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

Completed

• Conditions: Dynamic T2 Preparation
• Interventions: Procedure: MRI; Procedure: coronary angiography

• Registration Number: NCT02449083
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-20
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 3	coronary angiography	Patients with chronic obstructive pulmonary disease with indication to coronary angiography
Arm 1	MRI	Patients with indication for MRI and coronary angiography
Arm 2	MRI	Patients with atrioseptal or ventriculoseptal Shunt with indication to coronary angiography
Arm 2	coronary angiography	Patients with atrioseptal or ventriculoseptal Shunt with indication to coronary angiography
Arm 1	coronary angiography	Patients with indication for MRI and coronary angiography
Arm 3	MRI	Patients with chronic obstructive pulmonary disease with indication to coronary angiography

Primary Outcome Measures

Name	Time	Method
ventricular volumetry	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

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

Trial Locations

Locations (1)

University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany