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出境医 / 临床实验 / Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease
Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease
Study Description
Brief Summary:
Non-obstructive coronary artery disease (CAD), particularly common in women, has been associated with impaired quality of life and risk of recurrent hospitalizations. Several studies have also demonstrated increased risk of incident acute coronary events and mortality.
The main objective of the project is to assess the association between coronary artery plaque features by coronary CT angiography and long term prognosis in a large unselected population undergoing CT coronary angiography due to stable angina and suspected myocardial ischemia from the Norwegian Registry for Invasive Cardiology (NORIC) diagnosed with non-obstructive CAD by coronary CT angiography.
| Condition or disease | Intervention/treatment |
|---|---|
| Coronary Artery Disease Plaque, Atherosclerotic | Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE |
Detailed Description:
Patients with stable angina and non-obstructive coronary artery disease by CT coronary angiography will be selected from the Norwegian Registry of Invasive Cardiology (NORIC). This is a national quality control registry run and controlled by the Norwegian Institute of Public Health (www.fhi.no). All CT coronary angiograms will be reanalyzed using advanced post-processing analysis software to assess coronary artery plaque burden, distribution and composition. Through linking with the Norwegian Cardiovascular Disease Registry and the Cause of Death Registry (www.fhi.no) we will be able to assess the association between long-term prognosis (5 years) and coronary artery plaque features.
Study Design
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Covariates of Coronary Artery Plaque Burden and Composition by CT Coronary Angiography in Women and Men With Stable Angina and Non-obstructive Coronary Artery Disease - Analysis From the NORIC Registry |
| Actual Study Start Date : | February 15, 2018 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2023 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
High and low coronary artery plaque burden
Patients with high plaque burden defined as plaque in >=4 segments of the coronary tree and low plaque burden as plaque in <4 segments of the coronary tree assessed by postprocessing of CT coronary angiography images and cardiovascular events and mortality.
|
Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE
Assessment of segmental plaque volume and composition
|
Outcome Measures
Primary Outcome Measures :
- Cardiovascular mortality and nonfatal acute myocardial infarction [ Time Frame: 5 years ]Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction
Secondary Outcome Measures :
- All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures [ Time Frame: 5 years ]All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients from the NORIC registry undergoing CT coronary angiography due to chest pain and suspected myocardial ischemia and diagnosed with non-obstructive coronary artery disease between 2013-2017.
Criteria
Inclusion Criteria:
- Stable angina
- Non-obstructive coronary artery disease by CT coronary angiography defined as <50% stenosis (lumen diameter reduction)
Exclusion Criteria:
- Obstructive coronary artery disease
- Unstable angina
- Previous myocardial infarction, heart surgery or percutaneous coronary interventions
Contacts and Locations
Locations
| Norway | |
| Department of Clinical Science, University of Bergen | |
| Bergen, Norway, 5021 | |
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
| Principal Investigator: | Mai Tone Lønnebakken, MD phd | University of Bergen |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 2, 2019 | ||||
| First Posted Date | July 5, 2019 | ||||
| Last Update Posted Date | July 8, 2019 | ||||
| Actual Study Start Date | February 15, 2018 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Cardiovascular mortality and nonfatal acute myocardial infarction [ Time Frame: 5 years ] Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction
|
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| Original Primary Outcome Measures |
Primary endpoint [ Time Frame: 5 years ] Composite of deaths caused by cardiovascular disease and nonfatal acute myocardial infarction
|
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| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures [ Time Frame: 5 years ] All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures
|
||||
| Original Secondary Outcome Measures |
Secondary endpoint [ Time Frame: 5 years ] All-cause mortality, hospitalization due to cardiovascular disease and revascularization procedures
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Coronary Artery Plaque Burden in Stable Angina and Non-obstructive Coronary Artery Disease | ||||
| Official Title | Covariates of Coronary Artery Plaque Burden and Composition by CT Coronary Angiography in Women and Men With Stable Angina and Non-obstructive Coronary Artery Disease - Analysis From the NORIC Registry | ||||
| Brief Summary |
Non-obstructive coronary artery disease (CAD), particularly common in women, has been associated with impaired quality of life and risk of recurrent hospitalizations. Several studies have also demonstrated increased risk of incident acute coronary events and mortality. The main objective of the project is to assess the association between coronary artery plaque features by coronary CT angiography and long term prognosis in a large unselected population undergoing CT coronary angiography due to stable angina and suspected myocardial ischemia from the Norwegian Registry for Invasive Cardiology (NORIC) diagnosed with non-obstructive CAD by coronary CT angiography. |
||||
| Detailed Description | Patients with stable angina and non-obstructive coronary artery disease by CT coronary angiography will be selected from the Norwegian Registry of Invasive Cardiology (NORIC). This is a national quality control registry run and controlled by the Norwegian Institute of Public Health (www.fhi.no). All CT coronary angiograms will be reanalyzed using advanced post-processing analysis software to assess coronary artery plaque burden, distribution and composition. Through linking with the Norwegian Cardiovascular Disease Registry and the Cause of Death Registry (www.fhi.no) we will be able to assess the association between long-term prognosis (5 years) and coronary artery plaque features. | ||||
| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | 5 Years | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients from the NORIC registry undergoing CT coronary angiography due to chest pain and suspected myocardial ischemia and diagnosed with non-obstructive coronary artery disease between 2013-2017. | ||||
| Condition |
|
||||
| Intervention | Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE
Assessment of segmental plaque volume and composition
|
||||
| Study Groups/Cohorts | High and low coronary artery plaque burden
Patients with high plaque burden defined as plaque in >=4 segments of the coronary tree and low plaque burden as plaque in <4 segments of the coronary tree assessed by postprocessing of CT coronary angiography images and cardiovascular events and mortality.
Intervention: Diagnostic Test: Coronary artery plaque assessment by CT coronary angiography QAngio CT RE
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment |
1400 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 2023 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Norway | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04009421 | ||||
| Other Study ID Numbers | 1573 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Mai Tone Lønnebakken, University of Bergen | ||||
| Study Sponsor | University of Bergen | ||||
| Collaborators | Haukeland University Hospital | ||||
| Investigators |
|
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| PRS Account | University of Bergen | ||||
| Verification Date | July 2019 | ||||
