- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05696379
Angiography Derived Index of Microcirculatory Resistance in Patients With Acute Myocardial Infarction
January 13, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of acute myocardial infarction (AMI) patients, and has been shown to be associated with poor prognosis.
Angiography derived index of micro-circulatory resistance (Angio-IMR) is a novel pressure-wire free approach to assess coronary microvascular disease with great diagnostic performance.
The current study will further investigate the prognostic value of Angio-IMR in patients with AMI in multicenter retrospective cohort.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted with a diagnosis of acute myocardial infarction underwent successful percutaneous coronary intervention.
Description
Inclusion Criteria:
- Acute myocardial infarction patients who underwent successful percutaneous coronary intervention
Exclusion Criteria:
- No appropriate coronary angiography images (inferior image quality, image loss, severe arteries overlap, or significant artifact)
- Previous coronary artery bypass graft
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
STEMI with high Angio-IMR
Patients with ST segment elevation myocardial infarction and high Angio-IMR
|
Angiography derived index of micro-circulatory resistance (Angio-IMR) post percutaneous coronary intervention.
|
|
STEMI with low Angio-IMR
Patients with ST segment elevation myocardial infarction and low Angio-IMR
|
Angiography derived index of micro-circulatory resistance (Angio-IMR) post percutaneous coronary intervention.
|
|
NSTEMI with high Angio-IMR
Patients with non-ST segment elevation myocardial infarction and high Angio-IMR
|
Angiography derived index of micro-circulatory resistance (Angio-IMR) post percutaneous coronary intervention.
|
|
NSTEMI with low Angio-IMR
Patients with non-ST segment elevation myocardial infarction and low Angio-IMR
|
Angiography derived index of micro-circulatory resistance (Angio-IMR) post percutaneous coronary intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac death or readmission for heart failure in 1 month
Time Frame: 1 month
|
Incidence of cardiac death or readmission for heart failure during first 1 month follow-up.
|
1 month
|
|
Cardiac death or readmission for heart failure in 6 months
Time Frame: 6 month
|
Incidence of cardiac death or readmission for heart failure during first 6 months follow-up.
|
6 month
|
|
Cardiac death or readmission for heart failure in 1 year
Time Frame: 1 year
|
Incidence of cardiac death or readmission for heart failure during first 1 year follow-up.
|
1 year
|
|
Cardiac death or readmission for heart failure in 2 years
Time Frame: 2 year
|
Incidence of cardiac death or readmission for heart failure during first 2 years follow-up.
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
December 13, 2022
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Estimate)
January 24, 2023
Study Record Updates
Last Update Posted (Estimate)
January 24, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-0878
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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