UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053793 |
|---|---|
| Receipt number | R000061396 |
| Scientific Title | Prevalence, Correlates, and Prognostic Relevance of Coronary Microvascular Dysfunction in Patients with Heart Failure and/or Cardiomyopathy (the PRECISION study) |
| Date of disclosure of the study information | 2024/03/09 |
| Last modified on | 2024/11/18 20:55:44 |
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Basic information
Public title
Prevalence, Correlates, and Prognostic Relevance of Coronary Microvascular Dysfunction in Patients with Heart Failure and/or Cardiomyopathy (the PRECISION study)
Acronym
Prevalence, Correlates, and Prognostic Relevance of Coronary Microvascular Dysfunction in Patients with Heart Failure and/or Cardiomyopathy (the PRECISION study)
Scientific Title
Prevalence, Correlates, and Prognostic Relevance of Coronary Microvascular Dysfunction in Patients with Heart Failure and/or Cardiomyopathy (the PRECISION study)
Scientific Title:Acronym
Prevalence, Correlates, and Prognostic Relevance of Coronary Microvascular Dysfunction in Patients with Heart Failure and/or Cardiomyopathy (the PRECISION study)
Region
| Japan |
Condition
Condition
Heart Failure, Cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate 1) the prevalence of coronary microvascular dysfunction, factors related to coronary microvascular dysfunction, and the prognostic value of coronary microvascular dysfunction, and 2) the relationship between coronary microvascular dysfunction and myocardial fibrosis as assessed by delayed contrast-enhanced computed tomography in patients with heart failure or cardiomyopathy in patients with heart failure or cardiomyopathy.
Basic objectives2
Others
Basic objectives -Others
To evaluate 1) the prevalence of coronary microvascular dysfunction, factors related to coronary microvascular dysfunction, and the prognostic value of coronary microvascular dysfunction, and 2) the relationship between coronary microvascular dysfunction and myocardial fibrosis as assessed by delayed contrast-enhanced computed tomography in patients with heart failure or cardiomyopathy in patients with heart failure or cardiomyopathy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of coronary microvascular dysfunction
Key secondary outcomes
(1) Relationship between coronary microvascular dysfunction and the following factors:
Patient characteristics
Laboratory tests
Biomarkers
UCG findings
Global ECV by cardiac CT
(2) Clinical outcomes at 1, 2, 3, 4, 5 years
Major adverse cardiovascular events, a composite of cardiovascular death and heart failure admission
All-cause death
Cardiovascular death
Non-cardiovascular death
Heart failure admission
Cerebrovascular events
Myocardial infarction
Unplanned coronary revascularization
Subgroup analysis
HFpEF,HFrEF
Cardiomyopathy (amyloidosis, hypertrophic cariomyopathy, dilated cariomyopathy, hypertensive heart disease, drug-induced cariomyopathy, sarcoidosis, tachycardia-induced cariomyopathy, etc)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with heart failure or cardiomyopathy undergoing coronary angiography and CMD assessment with pressure wire.
Key exclusion criteria
Acute coronary syndrome
Acute decompensated heart failure
Visual stenosis of 90% or more in the left anterior descending artery on coronary angiography
Renal dysfunction (GFR<30mL/min/1.73m2) not on dialysis
Allergy against contrast agents
Coronary artery bypass graft surgery
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1,Asahi,Matsumoto,,Nagano
TEL
0263373486
sunoharadaisuke@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sunohara |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1,Asahi,Matsumoto,,Nagano
TEL
0263373486
Homepage URL
sunoharadaisuke@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Hospital
Address
3-1-1,Asahi,Matsumoto,,Nagano
Tel
0263373486
sunoharadaisuke@shinshu-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
| 2024 | Year | 03 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061396
