UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058137 |
|---|---|
| Receipt number | R000066346 |
| Scientific Title | Observational prospective study to evaluate clinical significance of coronary artery spasm in patients with cardiovascular disease |
| Date of disclosure of the study information | 2025/06/15 |
| Last modified on | 2025/06/10 12:18:57 |
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Basic information
Public title
Observational prospective study to evaluate clinical significance of coronary artery spasm in patients with cardiovascular disease
Acronym
Observational prospective study to evaluate clinical significance of coronary artery spasm in patients with cardiovascular disease
Scientific Title
Observational prospective study to evaluate clinical significance of coronary artery spasm in patients with cardiovascular disease
Scientific Title:Acronym
Clinical investigation of coronary artery spasm in cardiovascular disease
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the influence of coexisting coronary spasm on the clinical course and long-term outcomes in patients with cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
Determining clinical and biochemical predictors of coronary spasm in cardiovascular disease.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
We will evaluate the following outcomes at 5 and 10 years after intracoronary acetylcholine provocation testing:
1. All-cause mortality
2. Cardiovascular death
3. Hospitalization for heart failure
4. Stroke
5. Coronary revascularization
6. Other surgical procedures
7. Other non-cardiac surgical interventions
Key secondary outcomes
We will investigate the association between coronary reactivity to intracoronary acetylcholine provocation and clinical as well as biochemical factors.
The following variables will be evaluated:
1. Clinical factors:
Age, sex, body mass index (BMI), smoking status, hypertension, diabetes mellitus, dyslipidemia, history of cardiovascular disease, family history of cardiovascular disease, and current medications.
2. Biochemical factors:
Total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 (ApoA1), apolipoprotein A2 (ApoA2), apolipoprotein C2 (ApoC2), apolipoprotein C3 (ApoC3), apolipoprotein E (ApoE), remnant-like particle cholesterol (RLP-C), free fatty acids (FFA), glucose, immunoreactive insulin (IRI), hemoglobin A1c (HbA1c), C-reactive protein (CRP), and fibrinogen.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized at Yamanashi University Hospital who meet all of the following criteria will be included:
1. Diagnosis of ischemic heart disease (angina pectoris or myocardial infarction) or heart failure
2. Underwent intracoronary acetylcholine provocation testing during hospitalization
3. Had blood biochemical tests performed during the hospital stay
Key exclusion criteria
The following cases will be excluded from the analysis:
1. Patients undergoing hemodialysis
2. Patients with malignant diseases
3. Patients with severe infections
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Takamitsu |
| Middle name | |
| Last name | Nakamura |
Organization
University of Yamanashi Hospital
Division name
Cardiovascular medicine
Zip code
409-3898
Address
Shimokato 1110, Chuo, Yamanashi
TEL
055-273-9590
takanaka@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Takamitsu |
| Middle name | |
| Last name | Nakamura |
Organization
University of Yamanashi Hospital
Division name
Cardiovascular medicine
Zip code
409-3898
Address
shimokato 1110, Chuo, Yamanashi
TEL
055-273-9590
Homepage URL
takanaka@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi, Department of Cardiovascular Medicine
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
University of Yamanashi Hospital
Address
Shimokato 1110, Chuo, Yamanashi, JAPAN
Tel
055-273-9590
takanaka@yamanashi.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
山梨大学附属病院（山梨県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2005 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2005 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients were prospectively followed-up every 2-3 months at a hospital by each patient's primary physician for a period of up to 10 years.
Management information
Registered date
| 2025 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066346
