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Trial record 3 of 3 for:    herpesvirus | Alzheimer Disease

Natural History of Atherosclerosis in Real-World Patients Underwent Computed Tomography Angiography (REALITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440646
Recruitment Status : Enrolling by invitation
First Posted : May 12, 2015
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Ural Institute of Cardiology
De Haar Research Task Force
Transfiguration Clinic
First Sverdlovsk Regional Clinical Hospital
Information provided by (Responsible Party):
Alexander Kharlamov, Ural Medical University

Brief Summary:

In a prospective cohort single-center observational study, 720-1080 chest pain patients ('all-comers' REALITY registry of CTA patients, Ural Institute of Cardiology, Yekaterinburg, Russia; www.cardio-burg.ru) with or without acute coronary syndrome will be enrolled who admitted to the chest pain outpatient center (The Heart Clinics, Yekaterinburg, Russia; www.hclinic.ru; Transfiguration Clinic, Yekaterinburg, Russia; www.pr-clinica.ru; First Sverdlovsk Regional Clinical Hospital, Yekaterinburg, Russia; http://www.okb1.ru/home/otdeleniya/otdelenie_rentgenohirurgicheskih_metodov_diagnostiki_i_lecheniya/) since September 2010 underwent functional testing and computed tomography angiography, and/ or 3D quantitative coronary angiography with or without further percutaneous coronary intervention. Subsequent plaque burden/ % stenosis (adjusted with technical limitations of CTA and 3D QCA), major adverse cardiovascular events (death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable or progressive angina) will be judged to be related to either originally treated (culprit) lesions or untreated (non-culprit) lesions. Moreover, the clinical potential of CTA vs 3D QCA in two real-world patient flows of the Chest Pain centre will be estimated with the special focus on safety (contrast-induced nephropathy, radiocontrast-induced thyroid dysfunction, and radiation dose). The diagnostic accuracy of both CTA and 3D QCA will be analyzed in deceased patients.

The follow-up period will achieve 3-5 years when retro- and prospectively collected clinical events and imaging outcomes will be determined at the hospital, in 1, 6, 12, 24, 36, 48 and 60 months after the first imaging examination.

The independent ethics expertise will be provided by the Ural Medical University, Yekaterinburg, Russia (www.usma.ru). The monitoring of the clinical data with imaging as well as further CoreLab expertise (software of Medis) will be provided by De Haar Research Task Force, Amsterdam, the Netherlands.


Condition or disease Intervention/treatment
Coronary Atherosclerosis Coronary Artery Disease Radiocontrast-induced Thyroid Dysfunction Contrast-induced Nephropathy Cerebrovascular Disease Alzheimer's Disease Radiation: Coronary computed tomography angiography Radiation: Quantitative coronary angiography

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1080 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Natural History of Atherosclerosis Within the Concept of the Glagovian Artery Remodeling in REAL-world Chest Pain Population Underwent Computed Tomography Angiography and 3D Quantitative Coronary Angiography: Clinical potentIal and safeTY
Actual Study Start Date : May 2015
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CTA group
All-comers admitted to the chest-pain outpatient center with or without acute coronary syndrome underwent functional tests and coronary computed tomography angiography (CTA) (with intravenous contrast) with or without further quantitative coronary angiography (QCA) and percutaneous intervention (PCI).
Radiation: Coronary computed tomography angiography
The coronary arteries will be visualized with the 128-slice CT scan Aquilion CX (Toshiba, Tokyo, Japan).
Other Name: CTA

3D QCA group
All-comers admitted to the chest-pain outpatient center with or without acute coronary syndrome underwent functional tests and 3D quantitative coronary angiography (QCA) with or without implantation of stent.
Radiation: Quantitative coronary angiography
Coronaries will be shot with AXIOM Artis dFC (Siemens, Munich, Germany).
Other Name: QCA




Primary Outcome Measures :
  1. Change of per cent of plaque burden from baseline to follow-up as assessed by either CTA or QCA [ Time Frame: At 60 months after the baseline imaging procedure ]
    Plaque burden for both culprit and non-culprit lesions will be calculated as a lesion volume (vessel volume-lumen volume)/lumen volume x 100. The variable will be adjusted for computed tomography angiography (CTA) and 3D quantitative coronary angiography (QCA) due to technical limitations matching two groups.

  2. Number of participants with major adverse cardiac events that are related to plaque burden [ Time Frame: At 60 months after the baseline imaging procedure ]
    The composite of cardiac death, cardiac arrest, myocardial infarction, acute coronary syndrome, revascularization by coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI), or rehospitalization for angina for patients with both culprit- and non-culprit-lesion-related events. Event rates will be determined at: hospital, in 1, 6, 12, 24, 36, 48 and 60 months.


Secondary Outcome Measures :
  1. Change of serologic markers of inflammation from baseline to follow-up that are related to cardiovascular events and intervention [ Time Frame: At 60 months after the baseline imaging procedure ]
    Variables will be evaluated for predictive value relative to recurrent events in mmol/L.

  2. Number of participants with procedural success [ Time Frame: At 60 months after the baseline imaging procedure ]
    This is the cumulative variable comprising outcomes of each procedure. Ability to complete the imaging procedures without imaging device or procedure related complication.

  3. Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score I [ Time Frame: At 60 months after the baseline imaging procedure ]
    Calculated with the version 2.11 of the SYNTAX Score I calculator at: hospital, in 1, 6, 12, 24, 36, 48 and 60 months. The variable will be adjusted for CTA and 3D QCA due to technical limitations. CT SYNTAX score I will be calculated within recommendations Papadopoulou SL, et al, 2013 (JACC Cardiovasc Imaging. 2013 Mar;6(3):413-5. doi: 10.1016/j.jcmg.2012.09.013; http://www.syntaxscore.com/calculator/syntaxscore/frameset.htm).

  4. Change of complexity of coronary artery disease from baseline to follow-up as assessed by SYNTAX score II [ Time Frame: At 60 months after the baseline imaging procedure ]
    Calculated with the version 2.11 of the SYNTAX Score II calculator at: hospital, in 1, 6, 12, 24, 36, 48 and 60 months. The variable will be adjusted for CTA and 3D QCA due to technical limitations. CT SYNTAX score II will be calculated within recommendations Papadopoulou SL, et al, 2013 (JACC Cardiovasc Imaging. 2013 Mar;6(3):413-5. doi: 10.1016/j.jcmg.2012.09.013; http://www.syntaxscore.com/calculator/syntaxscore/framesetss2.htm).

  5. Change of fractional flow reserve (FFR) from baseline to follow-up that are related to the progress of atherosclerosis [ Time Frame: At 60 months after the baseline imaging procedure ]
    FFR less than 0.75 considered as hemodynamically significant and estimated for all the lesions. The variable will be adjusted for CTA and 3D QCA due to technical limitations. FFR will be compared with other variables to evaluate any correlations.

  6. Number of participants with contrast-induced nephropathy (CIN) [ Time Frame: At 60 months after the baseline imaging procedure ]
    This is the cumulative variable comprising outcomes of each procedure. Mehran's criteria for CIN diagnosis (validated at 48-72 hours after exposure of each imaging procedure) as well as CIN risk score will be assessed.

  7. Number of participants with radiocontrast-induced thyroid dysfunction [ Time Frame: At 60 months after the baseline imaging procedure ]
    The serum thyroid-stimulating hormone (TSH) will be examined as the initial test for screening. In case of the clinical manifestation of the thyroid dysfunction, the concentrations of the serum TSH, thyroid peroxidase (TPO) antibody titers, free thyroxine (T4) and free triiodothyronine (T3) will be assessed.

  8. Safety of QCA and CTA as assessed by the calculation of effective radiation dose [ Time Frame: At 60 months after the baseline imaging procedure ]
    The cumulative effective radiation dose (mSv), signal, noise, contrast (mean signal-signal in left ventricular myocardium), signal-to-noise ratio (SNR) and contrast-to-noise (CNR) ratio will be compared.

  9. Change of complexity of coronary artery disease from baseline to follow-up as assessed by Leaman Coronary Score [ Time Frame: At 60 months after the baseline imaging procedure ]
    Calculated within the recommendations of Leaman DM, et al, 1981 (Circulation 63, No. 2, 1981) at: hospital, in 1, 6, 12, 24, 36, 48 and 60 months. The variable will be adjusted for CTA and 3D QCA due to technical limitations. CT-Leaman score will be calculated within the recommendations of Mushtaq S, et al, 2015 (Circ Cardiovasc Imaging. 2015 Feb;8(2):e002332. doi: 10.1161/CIRCIMAGING.114.002332).

  10. Number of participants with encephalopathy [ Time Frame: At 60 months after the baseline imaging procedure ]
    The clinical manifestation (medical history, mental status testing with the mini-mental state examination (MMSE) and mini-cog, a physical and neurological exam) of degenerative and/ or paroxysmal encephalopathy will be evaluated with multi-slice computed tomography (MSCT)-screening of the cerebrovascular disease and Alzheimer's disease in association with markers of Herpes Simplex Virus Type 1 (HSV-1) and fungi.

  11. Number of chest pain patients with non-obstructive coronary artery disease [ Time Frame: At 60 months after the baseline imaging procedure ]
    Patients with the negative acute markers of the myocardial damage (myoglobin, troponin I, CK, CK-MB, NT-proBNP) and without hemodynamically significant (<50% stenosis) coronary atherosclerosis verified by MSCT

  12. Number of chest pain patients without coronary artery disease [ Time Frame: At 60 months after the baseline imaging procedure ]
    Patients with the negative acute markers of the myocardial damage (myoglobin, troponin I, CK, CK-MB, NT-proBNP) and without coronary atherosclerosis verified by MSCT


Biospecimen Retention:   Samples Without DNA
Blood samples to clarify the diagnosis of obstructive coronary artery disease and examine the level of thyroid hormones and kidney function


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All-incomers of the Chest Pain Outpatient Center, CPOC (Ural Institute of Cardiology, Yekaterinburg, Russia; Transfiguration Clinic, Yekaterinburg, Russia) with or without acute coronary syndrome underwent CTA and/ or 3D QCA with or without further PCI.
Criteria

Inclusion Criteria:

  • all-incomers with acute cardiac pain or angina equivalent consistent with manifestation of the stable or unstable coronary artery disease lasting greater than 10 minutes duration within the 72 hours prior to admission to the Chest Pain Outpatient Center (CPOC) between September 2010 and May 2015
  • patients who underwent CTA or 3D QCA after admission to the CPOC with or without further PCI
  • age above 21 years old
  • patient must have one or two-vessel disease in a native coronary vessel requiring or not requiring PCI without indications for bypass surgery with any SYNTAX score
  • lesions may be either de novo or restenotic
  • successful uncomplicated PCI must be performed in the culprit vessels and all culprit lesions before the patient is eligible for enrollment, but there should be no events or complications between the procedures of PCI in the past and 6 months prior to admission to CPOC
  • the non-culprit vessel should have no flow limiting lesions (plaque burden below 20%) and must be available for imaging. The non-culprit vessel must be considered safe for imaging evaluation

Exclusion Criteria:

  • any acute comorbidities
  • patient has had a documented ST-elevation acute myocardial infarction within the 24 hours prior to admission to the CPOC
  • unprotected left main lesion location
  • imaging evidence of severe calcification or marked tortuosity of the vessel
  • culprit lesion is located within or distal to an arterial or saphenous vein graft
  • untreated significant coronary lesion with more 50% diameter stenosis remaining in the culprit vessel after the planned intervention (branch stenosis is permitted)
  • multi-vessel disease requiring intervention in all three major coronary arteries
  • lesion or vessel contains visible thrombus within the imaging procedure
  • patient has additional lesion with requires an intervention within 180 days after the initial hospitalization
  • any diameter stenosis more than 50% in the non-culprit vessel
  • indications for bypass surgery within one year of enrollment with the SYNTAX above 22
  • serum creatinine more than 2.5 mg/dl
  • need for dialysis
  • endocrine disorders (diabetes is permitted) including pre-existing thyroid diseases
  • decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics, or intra-aortic balloon counterpulsation
  • patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine, or to contrast that cannot be adequately pre-medicated
  • presence of cardiac implants
  • presence of cardiogenic shock
  • patient has a known left ventricular ejection fraction less than 30%
  • refractory ventricular arrhythmia
  • acute conduction system disease requiring pacemaker
  • patient has had a recent PCI (last 6 months prior to admission to CPOC) unless the patient is undergoing a staged procedure for dual vessel treatment
  • patient has other severe medical illness or recent history of substance abuse that may cause non-compliance; confound the data interpretation or is associated with an anticipated limited life expectancy less than one year
  • prior participation in this study, or patient is currently enrolled in another investigational use device, imaging or drug study that has not been reached its primary endpoint
  • mental diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440646


Locations
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Netherlands
De Haar Research Task Force
Amsterdam, North Holland, Netherlands, 1069CD
Russian Federation
Transfiguration Clinic
Yekaterinburg, Sverdlovsk Oblast, Russian Federation, 620078
First Sverdlovsk Regional Clinical Hospital
Yekaterinburg, Sverdlovsk Oblast, Russian Federation, 620102
Ural Institute of Cardiology
Yekaterinburg, Russian Federation, 620144
Sponsors and Collaborators
Ural Medical University
Ural Institute of Cardiology
De Haar Research Task Force
Transfiguration Clinic
First Sverdlovsk Regional Clinical Hospital
Investigators
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Study Chair: Jan Gabinsky, M.D., Ph.D. Ural Institute of Cardiology, Yekaterinburg, Russia
Study Director: Alexander Kharlamov, M.D., FESC, FACC De Haar Research Task Force, Amsterdam, The Netherlands
Principal Investigator: Marina Freydlin, M.D., Ph.D. Ural Institute of Cardiology, Yekaterinburg, Russia
Principal Investigator: Lyudmila Dolnikovskaya, M.D. Chest Pain Outpatient Center (Heart Clinics), Yekaterinburg, Russia
Principal Investigator: Andrey Sysolyatin, M.D. Transfiguration Clinic, Yekaterinburg, Russia
Principal Investigator: Sergey Chernyshev, M.D. First Sverdlovsk Regional Clinical Hospital
Additional Information:
Publications:
Kharlamov AN. Why do we fail to achieve Glagovian atheroregression in lipid-lowering trials? Interventional Cardiology 7(5): 469-482, 2015. doi:10.2217/ica.15.37.

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Responsible Party: Alexander Kharlamov, Principal investigator and coordinator of the REALITY project, Ural Medical University
ClinicalTrials.gov Identifier: NCT02440646    
Other Study ID Numbers: REALITY
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The specific design of the study makes it infeasible to share the required information with the other researchers. Notwithstanding in case of the scientific inquiries regarding meta-analysis the situation might be considered.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Kharlamov, Ural Medical University:
Coronary artery disease
Computed tomography angiography
Quantitative coronary angiography
Natural history of atherosclerosis
Radiocontrast-induced thyroid dysfunction
Contrast-induced nephropathy
Plaque burden
Glagovian artery remodeling
Radiation dose
SYNTAX score
Fractional flow reserve
Additional relevant MeSH terms:
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Alzheimer Disease
Cerebrovascular Disorders
Kidney Diseases
Coronary Artery Disease
Coronary Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Myocardial Ischemia
Atherosclerosis
Dementia
Tauopathies
Arteriosclerosis