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

NCT04162561 | Completed

• 1 other identifier: PROFILE
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stable Ischemic Heart Disease

Keywords

quality of therapy; current clinical guidelines

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• all-cause mortality

  2 years

• Myocardial Infarction

  2 years

• Stroke

  2 years

• Unplanned hospitalization for cardiovascular diseases

  2 years

• Myocardial revascularization

  2 years

Interventions

Patients with documented IHD BEHAVIORAL

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with documented IHD having consequentially come for consultation to the specialized cardiology department of the scientific research center from December 31, 2017 to December 31, 2022

You may qualify if:

• 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:
• Positive results of the angina questionnaire (typical angina)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Location

Related Publications (4)

• 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 and the First Results. Rational Pharmacotherapy in Cardiology. 2020;16(1):75-81. (In Russ.) https://doi.org/10.20996/1819-6446-2020-02-08

  RESULT

• 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/10.20996/1819-6446-2021-01-06

  RESULT

• 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(3):306-310. (In Russ.) https://doi.org/10.20996/1819-6446-2022-06-12

  RESULT

• 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 Clinical GuideliNes) study. Cardiovascular Therapy and Prevention. 2022;21(9):3371. (In Russ.) https://doi.org/10.15829/1728-8800-2022-3371

  RESULT

Study Officials

• Sergey Martsevich, PhD

  National Research Center for Preventive Medicine

  STUDY CHAIR

• Ekaterina Zharkova, MD

  National Research Center for Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: December 31, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)