UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050291 |
|---|---|
| Receipt number | R000057241 |
| Scientific Title | The clinical significance of ST-segment depression on resting electrocardiogram: a retrospective observational study |
| Date of disclosure of the study information | 2023/02/09 |
| Last modified on | 2023/02/09 22:37:10 |
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Basic information
Public title
The significance of ST-segment depression on resting electrocardiogram in patients without prior cardiac disease and anginal chest pain
Acronym
The significance of ST-segment depression on resting electrocardiogram
Scientific Title
The clinical significance of ST-segment depression on resting electrocardiogram: a retrospective observational study
Scientific Title:Acronym
The significance of ST-segment depression on resting electrocardiogram
Region
| Japan |
Condition
Condition
left ventricular hypertrophy, silent myocardial ischemia
Classification by specialty
| Cardiology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the significance of ST-segment depression on resting electrocardiogram in patients without prior cardiac disease and anginal chest pain, by comparing with stress electrocardiogram and echocardiogram
Basic objectives2
Others
Basic objectives -Others
The validity of combining the results of three kinds of clinical tests, such as resting and stress electrocardiogram and echocardiogram, for early detection of cardiac diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Related factors of ST-segment depression on resting electrocardiogram in patients without prior cardiac disease and anginal chest pain; detection of silent myocardial ischemia on stress electrocardiogram and left ventricular hypertrophy on echocardiogram
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who visited the clinic, because of 1. non-anginal chest symptoms and/or 2. cardiac screening for non-cardiac surgery or colonoscopy.
Key exclusion criteria
1. patients with clinical signs of acute coironary syndrome, angina pectoris, syncope and congestive heart failure
2. Patients with electrocardiographic signs of left or right bundle branch blocks, pre-excitation syndrome, pacemaker implantation, sick sinus syndrome, any degree of atrioventricular blocks and tachyarrhythmias (paroxysmal supraventricular tachycardia, sustained or non-sustained ventricular tachycardia)
Target sample size
83
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Morita |
Organization
Saito Hospital
Division name
Department of Internal Medicine
Zip code
986-0873
Address
1-7-24, Yamashita-machi, Ishinomaki, Miyagi Prefecture, Japan
TEL
81-225-96-3251
qqv86uq9n@biscuit.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Morita |
Organization
Saito Hospital
Division name
Department of Internal Medicine
Zip code
986-0873
Address
1-7-24, Yamashita-machi, Ishinomaki, Miyagi Prefecture, Japan
TEL
81-225-96-3251
Homepage URL
qqv86uq9n@biscuit.ocn.ne.jp
Sponsor or person
Institute
Saito Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saito Hospital
Address
1-7-24, Yamashita-machi, Miyagi Prefecture, Japan
Tel
81-225-96-3251
qqv86uq9n@biscuit.ocn.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Publication delayed
Number of participants that the trial has enrolled
83
Results
ST-segment depression on resting electrocardiogram without prior cardiac disease and anginal chest pain is independently correlated with 1. age and 2. peak voltage of ST-segment depression in stress electrocardiogram and not independently correlated with left ventricular mass and left ventricular posterior wall thickness in end-diastole on echocardiography; on the contrary, it was not correlated with ischemic signs of stress electrocardiogram analyzed by ST-segment/ heart-rate loop method.
Results date posted
| 2023 | Year | 02 | Month | 08 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Submitted
Date of the first journal publication of results
Baseline Characteristics
Patients without prior cardiac disease and anginal chest pain who visited the lead principal investigator's (I, myself) cardiology clinic for diagnosis of the patient's non-anginal chest symptom and/or cardiac examination before non-cardiac surgery
Participant flow
For all the patients: 1. clinical history taking, 2. presence of complicated hypertension, diabetes mellitus and dyslipidemia, 3. cycle ergometer stress electrocardiogram and 4. echocardiographm were examined. Stress electrocardiogram was analyzed by ST-segment/ heart-rate loop method.
Adverse events
None
Outcome measures
Correlation with ST-segment depression on resting electrocardiogram: findings of resting electrocardiogram; Romhilt-Estes score (r = -0.35, p = 0.0014), Sokolow-Lyon's voltage (r = 0.0083, p = 0.93); findings of echocardiogram; left ventricular mass (r = -0.26, p = 0.017), left ventricular posterior wall thickness in end-diastole (r = -0.24, p = 0.029): findings of stress electrocardiogram; peak voltage of ST-segment depression (r = 0.31, p 0.0047), ST/ heart-rate slope (r = -0.0045, p = 0.69), recovery index (r = 0.045, p = 0.69): basic characteristics; age (r = -0.25, p = 0.024)
Receiver operating characteristics (ROC) curves on resting electrocardiographic parameters for estimating left ventricular mass: voltage of ST-segment depression (AUC = 0.62), Sokolow-Lyon's voltage (AUC = 0.53, p = 0.47), Romhilt-Estes score (r = 0.53, p = 0.30), significance test was done comparing AUC of Sokolow-Lyon's voltage and Romhilt-Estes score with that of voltage of ST-segment depression
Multiple logistic regression analysis for voltage of ST-segment depression on resting electrocardiogram: likelihood ratio = 20.91, p < 0.001; age (OR = 1.07, p = 0.015); peak voltage of ST-segment depression on stress electrocardiogram (OR = 0.00, p = 0.004); left ventricular mass (OR = 1.00, P = 0.061), left ventricular posterior wall thickness on end-diastole (OR = 0.94, p = 0.744)
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 1994 | Year | 07 | Month | 01 | Day |
Date of IRB
| 1994 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 1994 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 09 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 09 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 09 | Day |
Other
Other related information
To elucidate the significance of ST-segment depression on resting electrocardiogram in patients without prior cardiac disease and anginal chest pain, by comparing resting and cycle ergometer stress electrocardiogram and echocardiogram. According to this comparison, it is investigated whether the ST-segment depression on resting electrocardiogram is due to 1. silent myocardial ischemia, 2. left ventricular hypertrophy and 3. some other factors. Other parameters: age and gender; complications of hypertension, diabetes mellitus and dyslipidemia were also investigated. The study design was retrospective observational study by searching medical records, electrocardiograms and echocardiograms.
This study was started by the lead principal investigator, (I, myself), when working in Soma General Hospital in 1994 ~ 1997. There was no Research Ethics Committee then in that hospital, and I could enroll only 10 cases, mainly because patients didn't consent to undertake stress test. After an interruption, I enrolled 73 patients in Kojirakawa Shiseido Hospital, in which I served 2006 ~ 2011.
In 2011, data entry was completed.
Management information
Registered date
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057241
