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Completed

NCT Number: NCT03234023

Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)

DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.

CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored outhospital not inhospital supervised. MAIN OBJECTIVE: To determine the incidence of major adverse events (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Ferrol, Ferrol, A Coruña, Spain

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About this study

The SPRING study aims to learn whether a remote, nurse-guided secondary prevention program reduces adverse events in patients who suffer an infarction during the subsequent one-year period. The SPRING study focuses not only on adverse events but also on the patients' state of life in terms of diet, physical exercise, emotional state, tobacco use, and adherence to medical treatment. Nursing is a profession in charge of preserving the health of patients, which is why the remote secondary cardiovascular prevention program of this study is coordinated by a nurse.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who have suffered an ACS in the health area of A Coruña or Ferrol from the beginning of the study inclusion period until reaching the fixed sample size.
  • Ages between 18 and 75 years.
  • Patients with ability to read and understand the participation sheet in the study.
  • Patients signing informed consent to participate in the study.
  • Patients living in the health care area of HUAC or HUF.

Exclusion criteria

  • Patients who are dependent for the Basic Activities of Daily Living (BADL) or who suffer from severe cognitive impairment (which makes reliable anamnesis impossible).
  • Patients with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%.
  • Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.

Treatment and study plan

Intervention Group

Behavioral

Offer recommendations of healthy living habits and control of pharmacy administration

Primary outcomes

  1. major adverse events

    Time frame: 1 year

    total mortality, new ACS, coronary revascularization, hospitalization for any cause

Secondary outcomes

  1. cardiovascular mortality

    Time frame: 1 year

    cardiovascular mortality

  2. cardiovascular hospitalization

    Time frame: one year

    cardiovascular hospitalization

  3. stroke

    Time frame: 1 year

    stroke

  4. tobacco

    Time frame: 1 year

    questionnaire

  5. physical activity

    Time frame: 1 year

    mets

  6. nutrition

    Time frame: 1 year

    mediterranean diet

  7. emotion state

    Time frame: 1 year

    questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital A Coruña

Other

Registry information

Official study title

A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomized Controlled Trial

Acronym: SPRING

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jul 31, 2017
Registry last updated
Dec 9, 2024

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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