Coronary Artery Disease Clinical Trial
— DANCAPOfficial title:
Coronary Artery Plaque Burden in Asymptomatic Danish Men Aged 65-75 Years and the Relation to Glycemic Status. A Coronary CT Angiography (CCTA) Study.
NCT number | NCT04525508 |
Other study ID # | 01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | June 2019 |
Verified date | September 2020 |
Source | Svendborg Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cardiovascular disease (CVD) is one of the leading causes of death in the Western Society.
Patients with type 2 diabetes mellitus (T2DM) or dysglycemia have an increased risk of
developing CVD. Furthermore, T2DM have an increased risk of developing heart failure,
especially non-systolic, whether or not this is correlated to stepwise abnormal glycemic
status is not fully investigated.
The aims of this study are to investigate association between 1) Coronary plaque burden and
morphology to glycemic status (normal glucose tolerance (NGT), dysglycemia (impaired fasting
glucose (IFG) or impaired glucose tolerance (IGT)) and diabetic oral glucose tolerance test
(OGTT) in participants without known T2DM), 2) Coronary plaque burden and morphology to
diastolic and systolic function of the left ventricle including 2D speckle-tracking
assessments, 3) Glycemic status to diastolic and systolic function of the left ventricle
including 2D speckle-tracking assessments
In this descriptive study, 500-800 asymptomatic men aged 65-75 without known diabetes will be
included and divided into three subpopulations according to glycemic status. Blood sample,
oral glucose tolerance test (OGTT), echocardiography and Coronary CT Angiography (CCTA) will
be performed at inclusion
Status | Completed |
Enrollment | 488 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 65 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 65-75 years - Capable of giving written informed consent - Participates in the DANCAVAS study Exclusion Criteria: - Body mass index (BMI) >35 - Atrial fibrillation and other tachyarrhythmia that unable CCTA analysis - Estimates Glomerular filtration rate (eGFR) <45 ml/min - Contrast allergy - Untreated hyperthyroid - History of CAD or Apoplexia - Symptoms of CAD - Known Diabetes Mellitus |
Country | Name | City | State |
---|---|---|---|
Denmark | Cardiovascular Research Unit, OUH Svendborg Hospital | Svendborg |
Lead Sponsor | Collaborator |
---|---|
Svendborg Hospital | Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Association between insulin resistance to coronary artery plaque burden and morphology. | To evaluate the possible association between insulin resistance to coronary artery plaque burden and morphology in asymptomatic men, age 65-75 years without known T2DM. We will use HOMA-IR to asses the insulin resistance. | Baseline | |
Other | Correlation between insulin resistance to diastolic and systolic function of the left ventricle. | To evaluate the relation between insulin resistance to diastolic and systolic function of the left ventricle in asymptomatic men, aged 65-75 years without known T2DM. | Baseline | |
Other | Correlation between inflammatory biomarkers eg. TNF-alpha and Hs-CRP to coronary artery plaque burden and morphology. | To evaluate the correlation between inflammatory biomarkers eg. TNF-alpha and Hs-CRP to coronary artery plaque burden and morphology in a population consisting of asymptomatic men, aged 65-75 years, without known T2DM. | Baseline | |
Other | Association between glycemic status to left ventricular hypertrophy. | To evaluate the association between glycemic status to left ventricular hypertrophy in asymptomatic men, aged 65-75 years, without known T2DM. | Baseline | |
Other | Correlation between risk factors for ischemic heart disease to coronary artery plaque burden and morphology. | To evaluate the correlation between risk factors for ischemic heart disease to coronary artery plaque burden and morphology in asymptomatic men, aged 65-75 years, without known T2DM | Baseline | |
Other | Correlation between plaque burden and morphology to future cardiovascular events. | To evaluate the correlation between plaque burden and morphology to future cardiovascular events during five years of follow up, in a population of asymptomatic men aged 65-75 years without known T2DM. | Baseline - 5 years | |
Other | Impact of glycemic status to future cardiovascular events. | To evaluate the impact of glycemic status to future cardiovascular events during five years of follow up, in a population of asymptomatic men aged 65-75 years without known T2DM. | Baseline - 5 years | |
Other | Association between coronary plaque burden and morphology to post-systolic shortening. | To evaluate the impact of coronary plaque burden and morphology to post-systolic shortening in asymptomatic men, aged 65-75 years without known T2DM. | Baseline | |
Primary | Correlation between glycemic status to coronary plaque burden and morphology. | To evaluate the correlation between glycemic status (NGT, dysglycemia or Diabetic OGTT in patients without known T2DM) to plaque burden and morphology in asymptomatic men, aged 65-75 years. Plaque burden analyzed per vessel is defined as either percent atheroma volume (PAV), total atheroma volume (TAV) or normalized atheroma volume (NAV). Plaque morphology will include per plaque analysis of LAP (noncalcified plaque), remodeling indices (RI), spotty calcification and degree of stenosis where a significant stenosis is defined as >70 % of the luminal area. Above mentioned definitions of plaque burden and morphology is further explained in detail in Study Description above. | Baseline | |
Secondary | Association between coronary artery plaque burden and morphology to diastolic and systolic function of the left ventricle. | To evaluate the correlation between coronary artery plaque burden and morphology to diastolic and systolic function of the left ventricle in asymptomatic men, aged 65-75 years without known T2DM. We will use EF and 2D speckle-tracking to asses the systolic function of the left ventricle. | Baseline | |
Secondary | Association between glycemic status to diastolic and systolic function of the left ventricle. | To evaluate the correlation between glycemic status to diastolic and systolic function of the left ventricle in a population of asymptomatic men, aged 65-75 years without known T2DM. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |