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Completed

NCT Number: NCT04162561

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Research Center for Preventive Medicine

Moscow, 101990, Russia

About this study

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.

Who can participate

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:

  • 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

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

Treatment and study plan

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).

Primary outcomes

  1. Adherence to life-modifying treatment

    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.

  2. Achievement of the target LDL-C and BP levels

    Time frame: 1 year

    Target LDL-C levels - less than 1.8 mmol/l, target BP levels - less than 140/90 mmHg

Secondary outcomes

  1. all-cause mortality

    Time frame: 2 years

  2. Myocardial Infarction

    Time frame: 2 years

    description - the total number of events

  3. Stroke

    Time frame: 2 years

    description - the total number of events

  4. Unplanned hospitalization for cardiovascular diseases

    Time frame: 2 years

    description - the total number of events

  5. Myocardial revascularization

    Time frame: 2 years

    description - the total number of events

  6. improvement of the functional class of angina in at least 1-grade level

    Time frame: 1 year

    Assessment of the functional class of angina will be made according to the Canadian Cardiovascular Society grading of angina pectoris

  7. Compliance to life-modifying treatment

    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.

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2019
Registry last updated
Mar 15, 2023

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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