Cardiovascular DiseasesNCT03472898
Gated SPECT Abnormality With J Point Elevation
An observational study of Cardiovascular Diseases and Electrocardiogram: Electrical Alternans, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators present an interesting co-incidence of Gated wall abnormality in the inferolateral wall in normal sestamibi myocardial perfusion images with J wave in the inferior derivations of the ECG in a patient. Read more about this study
- Who is it for?
- Ages 55 to 55 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Electrocardiogram: Electrical Alternans, Myocardial Ischemia
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2017to 17 Jan 2018
- 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 55 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: Case Report
Who may be able to join
- Case Report
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Unidentified Association of Gated SPECT Abnormality With J Point Elevation
The investigators present an interesting co-incidence of Gated wall abnormality in the inferolateral wall in normal sestamibi myocardial perfusion images with J wave in the inferior derivations of the ECG in a patient. The subsequent coronary angiography demonstrated 80% mid right coronary artery (RCA) stenosis, which was intervened with a drug-eluting stent. The investigators conclude that even though the myocardial perfusion is normal, the association of gated wall abnormality with J wave presentation within the same location should be further evaluated.
Read the detailed description
The isolated J-point elevation considered as a type of "early repolarization" pattern (ER), is commonly been regarded as a benign finding. However, ER associations with arrhythmic sudden death from CAD or sudden cardiac death due to either idiopathic ventricular fibrillation have been shown. A recent study reported that ER especially in inferior leads, was related to worse cardiac outcomes in patients with CAD and they argue that ER in patients with CAD seems to be associated with the myocardial scar in the absence of pathologic Q waves.
Likewise, it is rare to detect clinically important gated SPECT abnormalities in normal myocardial perfusion studies with normal transient ischemic dilatation (TID) score and without any right ventricular uptake or any pulmonary uptake. Normal myocardial perfusion findings with wall motion abnormalities are frequently encountered in the interventricular septum of the patients who have previous bypass surgery or in patients with left bundle branch block (LBBB). However, the presented patient did not have the history of any intervention or LBBB. Perfusion and function discordance can be encountered in non-ischemic dilated cardiomyopathy patients; nonetheless, EF is markedly reduced in these patients.
The presented case, J point elevation in the ECG associated with relative wall motion abnormality was an important clue to determine CAD in the lack of evident perfusion defects or significant ECG findings.
The presence of wall motion abnormalities during stress study to predict CAD in patients with normal perfusion pattern, owing to balanced ischemia, was not only reported in multi-vessel disease but also in single-vessel disease without having presented the association between either regional wall motion abnormality or a localized particular ECG pattern and culprit lesion territory.
The interesting part of the presented case is, notwithstanding the myocardial perfusion pattern is normal, the abnormal gated finding with ECG changes having the concordant localization can be a significant milestone on the way to the diagnosis. To the best of investigators knowledge, the association between J point elevation and wall motion abnormality have not been described yet. Therefore, the investigators would like to draw attention to the importance of adjoining trivial ECG changes and wall motion abnormality for readers anymore.
- Conditions
- Cardiovascular Diseases, Electrocardiogram: Electrical Alternans, Myocardial Ischemia, Early Repolarization Syndrome, Left Ventricular Hypokinesia
- Medical subject headings
- Cardiovascular Diseases, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Case Report Proposal
Cure
Measured: December 2017-January 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start27 Dec 2017
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aylin AKBULUT, Ankara Education and Research Hospital
- Investigators
- Aylin Akbulut, Study chair, Ankara Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472898
- Sponsor's protocol ID
- 0001
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Unidentified Association of Gated SPECT Abnormality With J Point Elevation
- ClinicalTrials.gov ID
- NCT03472898
- Acronym / sponsor ID
- 0001
- Conditions
- Cardiovascular Diseases, Electrocardiogram: Electrical Alternans, Myocardial Ischemia, Early Repolarization Syndrome, Left Ventricular Hypokinesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 21 Mar 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.
The investigators present an interesting co-incidence of Gated wall abnormality in the inferolateral wall in normal sestamibi myocardial perfusion images with J wave in the inferior derivations of the ECG in a patient. The subsequent coronary angiography demonstrated 80% mid right coronary artery (RCA) stenosis, which was intervened with a drug-eluting stent. The investigators conclude that even though the myocardial perfusion is normal, the association of gated wall abnormality with J wave presentation within the same location should be further evaluated.
Detailed description
The isolated J-point elevation considered as a type of "early repolarization" pattern (ER), is commonly been regarded as a benign finding. However, ER associations with arrhythmic sudden death from CAD or sudden cardiac death due to either idiopathic ventricular fibrillation have been shown. A recent study reported that ER especially in inferior leads, was related to worse cardiac outcomes in patients with CAD and they argue that ER in patients with CAD seems to be associated with the myocardial scar in the absence of pathologic Q waves.
Likewise, it is rare to detect clinically important gated SPECT abnormalities in normal myocardial perfusion studies with normal transient ischemic dilatation (TID) score and without any right ventricular uptake or any pulmonary uptake. Normal myocardial perfusion findings with wall motion abnormalities are frequently encountered in the interventricular septum of the patients who have previous bypass surgery or in patients with left bundle branch block (LBBB). However, the presented patient did not have the history of any intervention or LBBB. Perfusion and function discordance can be encountered in non-ischemic dilated cardiomyopathy patients; nonetheless, EF is markedly reduced in these patients.
The presented case, J point elevation in the ECG associated with relative wall motion abnormality was an important clue to determine CAD in the lack of evident perfusion defects or significant ECG findings.
The presence of wall motion abnormalities during stress study to predict CAD in patients with normal perfusion pattern, owing to balanced ischemia, was not only reported in multi-vessel disease but also in single-vessel disease without having presented the association between either regional wall motion abnormality or a localized particular ECG pattern and culprit lesion territory.
The interesting part of the presented case is, notwithstanding the myocardial perfusion pattern is normal, the abnormal gated finding with ECG changes having the concordant localization can be a significant milestone on the way to the diagnosis. To the best of investigators knowledge, the association between J point elevation and wall motion abnormality have not been described yet. Therefore, the investigators would like to draw attention to the importance of adjoining trivial ECG changes and wall motion abnormality for readers anymore.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 55 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Case Report
Key inclusion criteria (1 listed)
- Case Report
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Case Report Proposal
Time frame: December 2017-January 2018
Cure
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 22 Mar 2018.
- 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.
Aylin Akbulut study chair
Ankara Education and Research Hospital
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 Cardiovascular Diseases and Electrocardiogram: Electrical Alternans, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 22 Mar 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 Turkey (Türkiye). 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?
Case Report Proposal (time frame: December 2017-January 2018). 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 22 Mar 2018.