MyocarditisNCT00511160
Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
A study testing Myocardial biopsies with TRU CUT 14 Gauge needle and Endomyocardial biopsies in people with Myocarditis, run by Udo Sechtem at 1 site in Germany.
Trial summary
Myocarditis is mainly caused by cardiotropic viruses. In recent time viruses found in endomyocardial biopsies mainly consist of parvovirus B19 (PVB19) and human herpesvirus 6 (HHV6). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis
- What is being tested?
- Myocardial biopsies with TRU CUT 14 Gauge needle and Endomyocardial biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Aug 2010
- Phase
- Interventional
- 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
Who may be able to join
- Cardiac surgery with cardiopulmonary bypass
Who cannot join
- No ability to give informed consent
- presence of so far accepted parvovirus/herpesvirus associated comorbidities
- contraindications for magnetic resonance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Robert Bosch Krankenhaus, Auerbachstrasse 110
Stuttgart, Baden-Wurttemberg, 70376
About this study
Official title: Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Myocarditis is mainly caused by cardiotropic viruses. In recent time viruses found in endomyocardial biopsies mainly consist of parvovirus B19 (PVB19) and human herpesvirus 6 (HHV6). A definite causal link between virus-genome detection of PVB19 and/or HHV6 (via pcr techniques)and cardiac inflammation and dysfunction is however still missing.
Primary objective:
Read more
To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae
Secondary objectives:
- Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
- Prognostic value of virus prevalence for the postoperative course
Primary hypothesis:
Patients without clinical evidence of myocarditis or myocarditic sequelae demonstrate to a significant lesser extent inflammatory activity and virus genome in their myocardium as compared to patients being clinical suspicious for myocarditis.
Read the detailed description
Prospective monocentric study with to 2 arms
Study arm: Cardiac surgery group, Control arm: Routine cardiology group Minimum of 100 patients included into the study arm
Inclusion criteria for the study arm:
Adult patients having cardiac surgery done under use of cardiopulmonary bypass
Data collection:
Past medical history, ecg, prior cardiovascular imaging (echo, ventriculography), cardiac magnetic resonance imaging (CMR), serologic studies, work-up of endomyocardial biopsies (histology, molecular-pathology, follow-up CMR.
- Conditions
- Myocarditis
- Being tested
- Myocardial biopsies with TRU CUT 14 Gauge needle, Endomyocardial biopsies
- Keywords
- myocarditis, parvovirus B19 (PVB19), human herpes virus 6 (HHV6), cardiac magnetic resonance tomography (CMR)
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial biopsies with TRU CUT 14 Gauge needleProcedure or surgery
Also called TRU CUT 14 Gauge needle
Myocardial needle biopsy and right atrial appendectomy
Endomyocardial biopsiesProcedure or surgery
The control arm C consists of routine-workup of patients with suspected myocarditis, independent of the study arm C, but with analogous screening methods and comparable biopsy sampling
| Study group | Role | What they receive |
|---|---|---|
| S | Active comparator | Study arm: Cardiac surgery group Receives: Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle |
| C | Active comparator | Routine cardiology group Receives: Procedure: Endomyocardial biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae
Measured: 2 years
Secondary outcomes (2)
Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
Measured: 2 years
Prognostic value of virus prevalence for the postoperative course
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Study suspended due to logistical/personnel difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udo Sechtem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Investigators
- Udo P Sechtem, MD, Study chair, Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, GermanyUlrich FW Franke, MD, Study director, Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, GermanyReinhardt Kandolf, MD, Study director, Director of Institute of Molecular Pathology University Tuebingen, GermanyHannibal Baccouche, MD, Principal investigator, Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, GermanyHardy Baumbach, MD, Principal investigator, Department of Cardiovascular Surgery, Robert Bosch Krankenhaus Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511160
- Sponsor's protocol ID
- RBK103
- Status last verified
- Oct 2016
- First submitted
- 2 Aug 2007
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
- ClinicalTrials.gov ID
- NCT00511160
- Acronym / sponsor ID
- RBK103
- Conditions
- Myocarditis
- Keywords
- myocarditis, parvovirus B19 (PVB19), human herpes virus 6 (HHV6), cardiac magnetic resonance tomography (CMR)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended due to logistical/personnel difficulties
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Udo SechtemUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Aug 2007 (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.
Myocarditis is mainly caused by cardiotropic viruses. In recent time viruses found in endomyocardial biopsies mainly consist of parvovirus B19 (PVB19) and human herpesvirus 6 (HHV6). A definite causal link between virus-genome detection of PVB19 and/or HHV6 (via pcr techniques)and cardiac inflammation and dysfunction is however still missing.
Primary objective:
To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae
Secondary objectives:
- Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
- Prognostic value of virus prevalence for the postoperative course
Primary hypothesis:
Patients without clinical evidence of myocarditis or myocarditic sequelae demonstrate to a significant lesser extent inflammatory activity and virus genome in their myocardium as compared to patients being clinical suspicious for myocarditis.
Detailed description
Prospective monocentric study with to 2 arms
Study arm: Cardiac surgery group, Control arm: Routine cardiology group Minimum of 100 patients included into the study arm
Inclusion criteria for the study arm:
Adult patients having cardiac surgery done under use of cardiopulmonary bypass
Data collection:
Past medical history, ecg, prior cardiovascular imaging (echo, ventriculography), cardiac magnetic resonance imaging (CMR), serologic studies, work-up of endomyocardial biopsies (histology, molecular-pathology, follow-up CMR.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S | Active comparator | Procedure: Myocardial biopsies with TRU CUT 14 Gauge needleStudy arm: Cardiac surgery group |
| C | Active comparator | Procedure: Endomyocardial biopsiesRoutine cardiology group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (3 listed)
- No ability to give informed consent
- presence of so far accepted parvovirus/herpesvirus associated comorbidities
- contraindications for magnetic resonance
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 |
|---|---|---|
| Myocardial biopsies with TRU CUT 14 Gauge needleAlso: TRU CUT 14 Gauge needleMyocardial needle biopsy and right atrial appendectomy | Procedure or surgery | S |
| Endomyocardial biopsiesThe control arm C consists of routine-workup of patients with suspected myocarditis, independent of the study arm C, but with analogous screening methods and comparable biopsy sampling | Procedure or surgery | C |
Primary outcome
To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae
Time frame: 2 years
2 secondary outcomes
Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
Time frame: 2 years
Prognostic value of virus prevalence for the postoperative course
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Study suspended due to logistical/personnel difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Udo P Sechtem, MD study chair
Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
Ulrich FW Franke, MD study director
Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, Germany
Reinhardt Kandolf, MD study director
Director of Institute of Molecular Pathology University Tuebingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardial biopsies with TRU CUT 14 Gauge needle and Endomyocardial biopsies in people with Myocarditis, run by Udo Sechtem 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Oct 2016. 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 was stopped early (reason given: Study suspended due to logistical/personnel difficulties). Results are not available in the source record.
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?
To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae (time frame: 2 years). 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 5 Oct 2016.