Dynamic T2 PreparationNCT02449083
Magnet Resonance Imaging to Evaluate of Dynamic T2 Preparation Puls by Patients With Shunt or Chronic Obstructive Pulmonary Disease
An observational study of Dynamic T2 Preparation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dynamic T2 Preparation
- What is being tested?
- MRI and coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD, who is planned for MRI and angiography
Who may be able to join
- patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD
- written informed consent
Who cannot join
- patients with ST-elevation
- contraindication for MRI
- heavy kidney disease
- pregnant or breast feeding women
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Dynamic T2 Preparation
- Being tested
- MRI, coronary angiography
- Keywords
- MRI, Shunt, COPD, Dynamic T2 Preparation Puls, new sequences, magnet resonance imaging, ventricular septal defect, Atrial septal defect
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Septal Defects, Ventricular, Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI
coronary angiographyProcedure or surgery
coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Patients with indication for MRI and coronary angiography Receives: Procedure: MRI; Procedure: coronary angiography | |
| Arm 2 | Patients with atrioseptal or ventriculoseptal Shunt with indication to coronary angiography Receives: Procedure: MRI; Procedure: coronary angiography | |
| Arm 3 | Patients with chronic obstructive pulmonary disease with indication to coronary angiography Receives: Procedure: MRI; Procedure: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (6)
oxygen partial pressure
Determination of oxygen partial pressure (pO2) during angiography
Measured: baseline
carbon dioxide partial pressure
Determination of carbon dioxide partial pressure (pCO2) during angiography
Measured: baseline
pH-value
Determination of pH-value od blood during angiography
Measured: baseline
Blood gas analysis
Determination of base excess of blood during angiography
Measured: baseline
Blood gas analysis
Determination of oxygen partial pressure (pO2), carbon dioxide partial pressure (pCO2), pH-value, base excess
Measured: baseline
Major adverse cardiac events
Major adverse cardiac events: death, new indication for angiography, hospitalization
Measured: 12 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dynamic T2 PreparationStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Britta Butzbach, MD, Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449083
- Sponsor's protocol ID
- 13-007
- Status last verified
- Nov 2015
- First submitted
- 19 Mar 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02449083
- Acronym / sponsor ID
- 13-007
- Conditions
- Dynamic T2 Preparation
- Keywords
- MRI, Shunt, COPD, Dynamic T2 Preparation Puls, new sequences, magnet resonance imaging, ventricular septal defect, Atrial septal defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Procedure: MRI, Procedure: coronary angiographyPatients with indication for MRI and coronary angiography |
| Arm 2 | – | Procedure: MRI, Procedure: coronary angiographyPatients with atrioseptal or ventriculoseptal Shunt with indication to coronary angiography |
| Arm 3 | – | Procedure: MRI, Procedure: coronary angiographyPatients with chronic obstructive pulmonary disease with indication to coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD, who is planned for MRI and angiography
Key inclusion criteria (2 listed)
- patients with atrial septal defect (ASD) or ventricular septal defect (VSD) and COPD
- written informed consent
Key exclusion criteria (4 listed)
- patients with ST-elevation
- contraindication for MRI
- heavy kidney disease
- pregnant or breast feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI | Procedure or surgery | Arm 1, Arm 2, Arm 3 |
| coronary angiographycoronary angiography | Procedure or surgery | Arm 1, Arm 2, Arm 3 |
Primary outcome
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
6 secondary outcomes
oxygen partial pressure
Time frame: baseline
carbon dioxide partial pressure
Time frame: baseline
pH-value
Time frame: baseline
Blood gas analysis
Time frame: baseline
Blood gas analysis
Time frame: baseline
Major adverse cardiac events
Time frame: 12 month after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britta Butzbach, MD principal investigator
Heinrich-Heine University, Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dynamic T2 Preparation, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventricular volumetry (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.