UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061589 |
|---|---|
| Receipt number | R000070220 |
| Scientific Title | Effects of App-based Risk Factor Modification in Patients with Ischemic Heart Disease: A Pilot Study |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/15 15:49:31 |
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Basic information
Public title
Effects of App-based Risk Factor Modification in Patients with Ischemic Heart Disease: A Pilot Study
Acronym
App-based Risk Factor Modification in IHD Patients: A Pilot Study
Scientific Title
Effects of App-based Risk Factor Modification in Patients with Ischemic Heart Disease: A Pilot Study
Scientific Title:Acronym
App-based Risk Factor Modification in IHD Patients: A Pilot Study
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the feasibility and preliminary effectiveness of a web-based remote intervention for risk factor modification in patients with ischemic heart disease
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Feasibility of the web-based intervention assessed by the frequency of data entry and the dropout rate
2. Achievement rate of management targets for cardiovascular risk factors (blood pressure, lipid profile, blood glucose, body weight, physical activity, and dietary nutrient intake)
Key secondary outcomes
Change from baseline in cardiovascular risk factors (blood pressure, lipid profile, blood glucose, body weight, physical activity, and dietary nutrient intake)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
This program is a 14-week program consisting of a 12-week lifestyle intervention and 5-day lifestyle assessments conducted before and after the intervention.
The lifestyle assessment is conducted for 5 days using wearable devices and web-based questionnaires. Physical activity, dietary intake, blood pressure, body weight, and other parameters are measured at home and recorded through a web application.
The lifestyle intervention mainly includes exercise and dietary interventions. For the exercise intervention, a target heart rate is determined based on the results of cardiopulmonary exercise testing (CPX), and participants perform exercise while self-monitoring their heart rate using a wearable device. Exercise data are transmitted to the server, and feedback is delivered through the application. In the dietary intervention, nutrients requiring improvement are identified through a web-based dietary assessment, and dietary improvement goals are established. Participants record their daily dietary intake, and feedback is provided every two weeks to support weight management and improvement of nutritional balance. Smoking cessation support is also provided for participants who request it. In addition, health information is delivered once a week to further support lifestyle improvement.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for chronic coronary syndrome or acute coronary syndrome
2. Patients who are willing to receive remote lifestyle intervention after hospital discharge
3. Adults aged 20 years or older who are able to understand the study and provide written informed consent.
Key exclusion criteria
1. Patients who show abnormal cardiovascular responses during exercise, including ischemic ST changes, serious arrhythmias, or abnormal blood pressure responses
2. Patients with atrial fibrillation
3. Patients with left ventricular ejection fraction (LVEF) < 40%
4. Patients undergoing hemodialysis
5. Patients who are unable to use a smartphone or tablet device
6. Patients judged by physician to be unsuitable for remote lifestyle intervention
7. Patients who will participate in outpatient cardiac rehabilitation after discharge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sumio |
| Middle name | |
| Last name | Yamada |
Organization
Aichi Medical University
Division name
Department of Cardiology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
yamadas@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuya |
| Middle name | |
| Last name | Funaki |
Organization
Aichi Medical University
Division name
Department of Cardiology
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
funakik@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Support Division, Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561-62-3311
kenshi@aichi-med-u.ac.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
| 2026 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070220
