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

NCT03234023 | Completed DMC

• 2 other identifiers: 2017/101SPRING
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Nutrition; Physical Activity; Secondary Prevention

Outcome Measures

Primary Outcomes (1)

• major adverse events

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

  1 year

Secondary Outcomes (7)

• cardiovascular mortality

  1 year

• cardiovascular hospitalization

  one year

• stroke

  1 year

• tobacco

  1 year

• physical activity

  1 year

Study Arms (2)

INTERVENTION GROUP

ACTIVE COMPARATOR

The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco.

Behavioral: INTERVENTION GROUP

CONTROL GROUP

NO INTERVENTION

The participants of this group are submitted to the standard intervention.

Interventions

INTERVENTION GROUP BEHAVIORAL

Offer recommendations of healthy living habits and control of pharmacy administration

INTERVENTION GROUP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital A Coruña: lead

Study Sites (2)

University Hospital of Ferrol

Ferrol, A Coruña, 15405, Spain

Location

University Hospital of A Coruña

A Coruña, Galicia, 15006, Spain

Location

Related Publications (1)

• Fernandez-Pombo CN, Aldama-Lopez G, Lorenzo-Carpente M, Lopez-Perez M, Marzoa-Rivas R, Rodriguez-Fernandez JA, Vazquez-Rodriguez JM. A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomised Controlled Trial. J Adv Nurs. 2025 May 15. doi: 10.1111/jan.17046. Online ahead of print.

  PMID: 40372009 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Study Officials

• Carmen Neri Fernández Pombo, PhD

  University Hospital A Coruña

  PRINCIPAL INVESTIGATOR

• Guillermo Aldama López, MD

  University Hospital A Coruña

  PRINCIPAL INVESTIGATOR

• José Manuel Vázquez Rodríguez, MD

  University Hospital A Coruña

  PRINCIPAL INVESTIGATOR

• Raquel Marzoa Rivas, MD

  University Hospital Ferrol

  PRINCIPAL INVESTIGATOR

• Manuel López Pérez, MD

  University Hospital Ferrol

  PRINCIPAL INVESTIGATOR

• Marta Lorenzo Carpente, Nurse

  University Hospital Ferrol

  PRINCIPAL INVESTIGATOR

• Jose Angel Rodriguez Fernández, MD

  University Hospital A Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 31, 2017
• Study Start: October 1, 2017
• Primary Completion: February 5, 2023
• Study Completion: February 5, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)