TherApy in stabLe Coronary Artery dIsease Patients According to Clinical GuideliNes (ALIGN)

Stable Ischemic Heart Disease Clinical Trial

Official title:

Trying to Improve Quality of therApy in Patients With stabLe Coronary Artery dIsease According to Current Clinical GuideliNes (ALIGN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162561
• Other study ID #: PROFILE
• Status: Completed
• Start date: December 31, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Positive results of the angina questionnaire (typical angina)

2. Positive exercise electrocardiography or stress echocardiography, plus one of the following criteria:

• ischemia documented by scintigraphy study

• invasive coronary angiography data (stenosis of at least 75% in at least one main coronary artery)

• previous coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG))

• previous myocardial infarction

• patients who had elective PCI or CABG

Exclusion Criteria:

• Patients with acute IHD (less than 30 days since the last ischemic event with or without invasive procedures for the treatment of the event)

• Patients' refuse to follow the study's graphic of doctors' visits

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Ischemic Heart Disease

Intervention

Behavioral:
• Patients with documented IHD
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).

Locations

Country	Name	City	State
Russian Federation	National Research Center for Preventive Medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

References & Publications (4)

Martsevich S.Y., Lukina Y.V., Zharkova E.D., Kutishenko N.P. Treatment Adherence to Drug Therapyin Patients with Stable Coronary Artery Disease During the COVID-19 Pandemic. Rational Pharmacotherapy in Cardiology. 2021;17(1):99-104. https://doi.org/10.209

Martsevich S.Yu., Zharkova E.D., Kutishenko N.P., Lukina Yu.V., Tolpygina S.N., Voronina V.P., Zagrebelnyy A.V. An Attempt to Accord the Quality of Therapy of Stable Coronary Heart Disease Patients with Current Clinical Guidelines (ALIGN study): Design an

Zharkova E.D., Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Drapkina O.M. Assessment of the Quality of Drug Therapy in Patients with Stable Coronary Artery Disease in the Second Stage of the ALIGN Study. Rational Pharmacotherapy in Cardiology. 2022;18

Zharkova E.D., Martsevich S.Yu., Lukina Yu.V., Kutishenko N.P., Drapkina O.M. The quality of received drug therapy in patients with stable coronary heart disease according to the ALIGN (TherApy in stabLe Coronary Artery dIsease Patients According to Clini

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to life-modifying treatment	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.	1 year
Primary	Achievement of the target LDL-C and BP levels	Target LDL-C levels - less than 1.8 mmol/l, target BP levels - less than 140/90 mmHg	1 year
Secondary	all-cause mortality		2 years
Secondary	Myocardial Infarction	description - the total number of events	2 years
Secondary	Stroke	description - the total number of events	2 years
Secondary	Unplanned hospitalization for cardiovascular diseases	description - the total number of events	2 years
Secondary	Myocardial revascularization	description - the total number of events	2 years
Secondary	improvement of the functional class of angina in at least 1-grade level	Assessment of the functional class of angina will be made according to the Canadian Cardiovascular Society grading of angina pectoris	1 year
Secondary	Compliance to life-modifying treatment	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.	1 year