Coronary Artery DiseaseDSB-SPECTNCT01380821
DNA Double-strand Breaks After SPECT
An observational study of Coronary Artery Disease, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Myocardial SPECT
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jan 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients clinically indicated to undergo myocardial SPECT.
Who may be able to join
- myocardial SPECT clinically indicated
Who cannot join
- acute leukaemia or lymphoma
- radiation or chemotherapy in the last 6 months
- x-ray or scintigraphy within the last 3 days
- age below 18 years
- eGFR of below 60 ml/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DNA Double-strand Breaks Following Myocardial Scintigraphy
Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.
The investigators are already conducting several other studies to prospectively compare the inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending these examinations to investigate the induced DSBs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation.
To evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. These examinations are routinely done by the Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the Federal Department for Radiological Protection. Blood samples will be taken from these patients at predefined time steps before and after the examination and DNA double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.
- Conditions
- Coronary Artery Disease
- Being tested
- Myocardial SPECT
- Keywords
- clinical indication for myocardial SPECT, suspected or known coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial SPECTRadiation
Myocardial SPECT according to clinical standards for patients with a clinical indication to undergo this imaging test.
| Study group | Role | What they receive |
|---|---|---|
| SPECT | Patients clinically indicated to undergo myocardial SPECT in our institution. Receives: Radiation: Myocardial SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation-induced DNA double-strand breaks after myocardial scintigraphy.
DNA double-strand breaks will be measured before and up to 48 hours after radiation.
Measured: 48 hours
Secondary outcomes (1)
Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.
DNA double-strand breaks will be compared with injected activity.
Measured: Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Marc Dewey, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380821
- Sponsor's protocol ID
- EA4/004/11
- Acronym
- DSB-SPECT
- Status last verified
- Apr 2013
- First submitted
- 22 Jun 2011
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Geisel D, Heverhagen JT, Kalinowski M, Wagner HJ. DNA double-strand breaks after percutaneous transluminal angioplasty. Radiology. 2008 Sep;248(3):852-9. doi: 10.1148/radiol.2483071686.
PubMed 18710979
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Double-strand Breaks Following Myocardial Scintigraphy
- ClinicalTrials.gov ID
- NCT01380821
- Acronym / sponsor ID
- DSB-SPECT / EA4/004/11
- Conditions
- Coronary Artery Disease
- Keywords
- clinical indication for myocardial SPECT, suspected or known coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Jun 2011 (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.
Ionizing radiation has a number of harmful effects in humans. The most important among these is the induction of cancer. It is assumed that damage to DNA in the nucleus of a single cell can induce cancer. Among the different types of lesions inducted, DNA double-strand breaks (DSBs) are considered to be the most relevant effects that can initiate carcinogenesis.
The investigators are already conducting several other studies to prospectively compare the inducted DSBs by coronary CT-angiography and conventional coronary angiography. Extending these examinations to investigate the induced DSBs by myocardial scintigraphy allows a comparison of all three relevant imaging methods of the heart that incorporate ionizing radiation.
To evaluate this, the investigators are planning to examine patients who are scheduled for a clinically indicated myocardial scintigraphy. These examinations are routinely done by the Department of Nuclear Medicine in either a 1-day or a 2-day protocol according to the diagnostic reference values of the Federal Department for Radiological Protection. Blood samples will be taken from these patients at predefined time steps before and after the examination and DNA double-strand breaks will be determined from these blood samples specifically considering the applied activity of the tracer and the exposition kinetics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPECT | – | Radiation: Myocardial SPECTPatients clinically indicated to undergo myocardial SPECT in our institution. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients clinically indicated to undergo myocardial SPECT.
Key inclusion criteria (1 listed)
- myocardial SPECT clinically indicated
Key exclusion criteria (5 listed)
- acute leukaemia or lymphoma
- radiation or chemotherapy in the last 6 months
- x-ray or scintigraphy within the last 3 days
- age below 18 years
- eGFR of below 60 ml/min
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 SPECTMyocardial SPECT according to clinical standards for patients with a clinical indication to undergo this imaging test. | Radiation | SPECT |
Primary outcome
Radiation-induced DNA double-strand breaks after myocardial scintigraphy.
Time frame: 48 hours
DNA double-strand breaks will be measured before and up to 48 hours after radiation.
1 secondary outcome
Comparison of radiation-induced DSBs with activity used for myocardial scintigraphy.
Time frame: Activity will be measured 5 min and 1h after injection of the technetium tracer for SPECT.
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 3 May 2013.
- Background: PubMed 18710979Geisel D, Heverhagen JT, Kalinowski M, Wagner HJ. DNA double-strand breaks after percutaneous transluminal angioplasty. Radiology. 2008 Sep;248(3):852-9. doi: 10.1148/radiol.2483071686.
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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.
Marc Dewey principal investigator
Charite University, Berlin, Germany
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 Coronary Artery Disease, run by Charite University, Berlin, Germany 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 5 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 3 May 2013. 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?
Radiation-induced DNA double-strand breaks after myocardial scintigraphy. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380821, which also lists 1 linked publication.
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 3 May 2013.