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

NCT ID: NCT04162561

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stable Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergey Martsevich, PhD

Role: STUDY_CHAIR

National Research Center for Preventive Medicine

Ekaterina Zharkova, MD

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Preventive Medicine

Locations

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National Research Center for Preventive Medicine

Moscow, , Russia

Site Status

Countries

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Russia

References

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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

Reference Type 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

Reference Type 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

Reference Type 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

Reference Type RESULT

Other Identifiers

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PROFILE

Identifier Type: -

Identifier Source: org_study_id

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