National Research Center for Preventive Medicine
Moscow, 101990, Russia
NCT Number: NCT04162561
The aim of this prospective cohort study is to assess the quality of therapy in patients with stable ischemic heart disease (IHD) who had never applied for specialized medical care for the last 3 years and try to accord their treatment with current clinical guidelines.
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Notify Me18 year and older
All sexes
Observational
Moscow, 101990, Russia
The purpose of this study is to assess the quality of therapy in patients having come for the first time consultation to the specialized cardiology department of the scientific research centre within the PROFILE registry and to try to correct therapy according to current clinical guidelines paying particular attention to reaching target blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), glycosylated haemoglobin - HbA1c (in patients with diabetes mellitus) levels, improving exercise tolerance and quality of life.
The first visit (V0) is an inclusion in the study. During this visit, an attempt to correct or start (if it had not been started before) antiplatelet, hypolipidemic, antihypertensive and antianginal therapy will be made.
The second visit (V1) is planned for each patient three months after the first visit (V0). During the second visit number of patients who reached target levels of BP, LDL-C, frequency of angina attacks will be assessed. If necessary, correction of therapy will also be made.
The third visit (V2) is planned for each patient one year after the first visit (V0). During the third visit reaching target BP, LDL-C levels, frequency of angina attacks will be assessed. If necessary, therapy correction will be recommended.
The last visit - telephone contact with patients - is expected in 2 years after the first visit. During that visit it is planned to assess life status, complications and current medical treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All patients with documented IHD having consequentially come for the first time for consultation to the specialized cardiology department of the scientific research center from December 31, 2017 to December 31, 2022.
Documented IHD:
Exclusion criteria
Assessment of patients' quality of life with the use of the Seattle Angina Questionnaire (SAQ), blood pressure levels (using the Korotkoff method, blood pressure is measured 3 times with 1-minute intervals on the hand with the higher blood pressure levels while sitting calm after a 5-minutes rest), laboratory methods (lipids, glycosylated hemoglobin levels), patients' adherence to treatment (original questionnaire), quality of patients' therapy taken at the time of visit, necessity of invasive coronary revascularization procedures (during all visits).
Time frame: 1 year
The Adherence scale of the Russian National Society of evidence based pharmacotherapy modified for patients with coronary heart disease will be used to assess patients' adherence to treatment. The patients will be asked questions about taking prescribed medications as recommended by a doctor.
The score system with the min value in the scale 0 and the max value 4 is used for the assessment of the results: 0 - adherent, 1-2 - partially adherent, 3 - partially non-adherent, 4 - non adherent.
Time frame: 1 year
Target LDL-C levels - less than 1.8 mmol/l, target BP levels - less than 140/90 mmHg
Time frame: 2 years
Time frame: 2 years
description - the total number of events
Time frame: 2 years
description - the total number of events
Time frame: 2 years
description - the total number of events
Time frame: 2 years
description - the total number of events
Time frame: 1 year
Assessment of the functional class of angina will be made according to the Canadian Cardiovascular Society grading of angina pectoris
Time frame: 1 year
Necessity of the use of the following drugs will be investigated for each patient: antiplatelets, anticoagulants, hypolipidemic drugs, beta-blockers, ACE-inhibitors/ARBs.
Later, percent of the drugs that each patient actually takes will be calculated (for example, three drugs are indicated and two are taken - (2/3)*100 = 66.6%).
In the end, the mean adherence to therapy in the investigated group will be calculated.
National Research Center for Preventive Medicine
Other Gov
Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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