Ischemic Heart DiseaseNCT03688815
Dipyridamole Induced Ischemia and Biomarkers
An observational study of Ischemic Heart Disease and Ischemic Attack, run by University of Pecs at 1 site in Hungary.
Trial summary
Analysis of certain biomarkers and transient myocardial perfusion deficit revealed by myocardial perfusion scintigraphy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease, Ischemic Attack
- What is being tested?
- myocardial perfusion scintigraphy
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2009to 1 Jan 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with IHD were enrolled.
Inclusion Criteria: 1. written informed consent. 2. clinical diagnosis of ischemic heart disease (IHD) -
Exclusion Criteria: 1. refused written informed consent. 2. lost data during follow-up
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the L-arginine Pathway Metabolites and Dipyridamole Stress Induced Transient Myocardial Ischaemia
Analysis of certain biomarkers and transient myocardial perfusion deficit revealed by myocardial perfusion scintigraphy.
Read the detailed description
The prospectively enrolled patients were followed up to 5 years. Adverse major events (MI, stroke, death) suffered during follow-up were retrospectively analysed.
- Conditions
- Ischemic Heart Disease, Ischemic Attack
- Being tested
- myocardial perfusion scintigraphy
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial perfusion scintigraphyDiagnostic test
Myocardial perfusion scintigraphy as it is described in the international literature.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ischemic heart disease | Patients with ischemic heart disease scheduled for myocardial perfusion scintigraphy were enrolled. Biomarkers were analysed form periferal blood. Patients outcome data were followed up to 5 years. Receives: Diagnostic Test: myocardial perfusion scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion abnormality
Myocardial perfusion was quantified based on myocardial perfusion scintigraphy (MPS).
Measured: 5 year follow-up after MPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Jan 2009
- Primary completion1 Jan 2010
- Study completion1 Jan 2017
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 Ischemic Heart DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tihamér Molnár, University of Pecs
- Investigators
- Tihamer Molnar, MD, Principal investigator, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688815
- Sponsor's protocol ID
- PTE3950
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan: publication of data in a peer-reviewed journal
Publications
Molnar T, Horvath A, Szabo Z, Vamos Z, Doczi T, Illes Z. Detection of silent cerebral microcirculatory abnormalities in patients with manifest ischemic coronary disease: a perfusion brain MRI study combined with dipyridamole stress. Scand Cardiovasc J. 2021 Apr;55(2):97-101. doi: 10.1080/14017431.2020.1821911. Epub 2020 Sep 18.
PubMed 32945202
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the L-arginine Pathway Metabolites and Dipyridamole Stress Induced Transient Myocardial Ischaemia
- ClinicalTrials.gov ID
- NCT03688815
- Acronym / sponsor ID
- PTE3950
- Conditions
- Ischemic Heart Disease, Ischemic Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2010 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
Analysis of certain biomarkers and transient myocardial perfusion deficit revealed by myocardial perfusion scintigraphy.
Detailed description
The prospectively enrolled patients were followed up to 5 years. Adverse major events (MI, stroke, death) suffered during follow-up were retrospectively analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ischemic heart disease | – | Diagnostic Test: myocardial perfusion scintigraphyPatients with ischemic heart disease scheduled for myocardial perfusion scintigraphy were enrolled. Biomarkers were analysed form periferal blood. Patients outcome data were followed up to 5 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with IHD were enrolled.
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 perfusion scintigraphyMyocardial perfusion scintigraphy as it is described in the international literature. | Diagnostic test | Patients with ischemic heart disease |
Primary outcome
Myocardial perfusion abnormality
Time frame: 5 year follow-up after MPS
Myocardial perfusion was quantified based on myocardial perfusion scintigraphy (MPS).
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 28 Sep 2018.
- Derived from this study: PubMed 32945202Molnar T, Horvath A, Szabo Z, Vamos Z, Doczi T, Illes Z. Detection of silent cerebral microcirculatory abnormalities in patients with manifest ischemic coronary disease: a perfusion brain MRI study combined with dipyridamole stress. Scand Cardiovasc J. 2021 Apr;55(2):97-101. doi: 10.1080/14017431.2020.1821911. Epub 2020 Sep 18.
- Regulation of Coronary Blood Flow in Health and Ischemic Heart DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD sharing plan: publication of data in a peer-reviewed journal
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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.
Tihamer Molnar, MD principal investigator
University of Pecs
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 Ischemic Heart Disease and Ischemic Attack, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. 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 Hungary. 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?
Myocardial perfusion abnormality (time frame: 5 year follow-up after MPS). 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 NCT03688815, 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 28 Sep 2018.