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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • AnkaraERH

    Ankara, Altindag, 06340

Other trials in Turkey (Türkiye)

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.

Medical subject headings
Cardiovascular Diseases, Myocardial Ischemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted21 Mar 2018
  2. Study start27 Dec 2017
  3. Primary completion17 Jan 2018
  4. Study completion17 Jan 2018

Resources

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)
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

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.

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