Acute Coronary SyndromeSPRINGNCT03234023
Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)
A study testing INTERVENTION GROUP in people with Acute Coronary Syndrome and Nutrition, run by University Hospital A Coruña at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome, Nutrition, Physical Activity
- What is being tested?
- INTERVENTION GROUP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Oct 2017to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University Hospital of A Coruña
A Coruña, Galicia, 15006
University Hospital of Ferrol
Ferrol, A Coruña, 15405
About this study
Official title: A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- INTERVENTION GROUP
- Medical subject headings
- Acute Coronary Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERVENTION GROUPBehavioural
Offer recommendations of healthy living habits and control of pharmacy administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: INTERVENTION GROUP |
| CONTROL GROUP | No intervention | The participants of this group are submitted to the standard intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse events
total mortality, new ACS, coronary revascularization, hospitalization for any cause
Measured: 1 year
Secondary outcomes (7)
cardiovascular mortality
cardiovascular mortality
Measured: 1 year
cardiovascular hospitalization
cardiovascular hospitalization
Measured: one year
stroke
stroke
Measured: 1 year
tobacco
questionnaire
Measured: 1 year
physical activity
mets
Measured: 1 year
nutrition
mediterranean diet
Measured: 1 year
emotion state
questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Oct 2017
- Primary completion5 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARMEN NERI FERNANDEZ POMBO, University Hospital A Coruña
- Investigators
- Carmen Neri Fernández Pombo, PhD, Principal investigator, University Hospital A CoruñaGuillermo Aldama López, MD, Principal investigator, University Hospital A CoruñaJosé Manuel Vázquez Rodríguez, MD, Principal investigator, University Hospital A CoruñaRaquel Marzoa Rivas, MD, Principal investigator, University Hospital FerrolManuel López Pérez, MD, Principal investigator, University Hospital FerrolMarta Lorenzo Carpente, Nurse, Principal investigator, University Hospital FerrolJose Angel Rodriguez Fernández, MD, Principal investigator, University Hospital A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234023
- Sponsor's protocol ID
- 2017/101
- Other IDs
- SPRING
- Acronym
- SPRING
- Status last verified
- Dec 2024
- First submitted
- 25 Jul 2017
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the participants can not be used by other researchers
Publications
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. 2026 Feb;82(2):1803-1818. doi: 10.1111/jan.17046. Epub 2025 May 15.
PubMed 40372009
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Nursing-Guided Secondary Prevention Programme in Acute Coronary Syndrome. The SPRING Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03234023
- Acronym / sponsor ID
- SPRING / 2017/101
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- University Hospital A CoruñaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION GROUP | Active comparator | Behavioral: INTERVENTION GROUPThe participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco. |
| CONTROL GROUP | No intervention | –The participants of this group are submitted to the standard intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTERVENTION GROUPOffer recommendations of healthy living habits and control of pharmacy administration | Behavioural | INTERVENTION GROUP |
Primary outcome
major adverse events
Time frame: 1 year
total mortality, new ACS, coronary revascularization, hospitalization for any cause
7 secondary outcomes
cardiovascular mortality
Time frame: 1 year
cardiovascular hospitalization
Time frame: one year
stroke
Time frame: 1 year
tobacco
Time frame: 1 year
physical activity
Time frame: 1 year
nutrition
Time frame: 1 year
emotion state
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 40372009Fernandez-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. 2026 Feb;82(2):1803-1818. doi: 10.1111/jan.17046. Epub 2025 May 15.
- Individual participant dataSharing planned: No. The data of the participants can not be used by other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Neri Fernández Pombo, PhD principal investigator
University Hospital A Coruña
Guillermo Aldama López, MD principal investigator
University Hospital A Coruña
José Manuel Vázquez Rodríguez, MD principal investigator
University Hospital A Coruña
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTERVENTION GROUP in people with Acute Coronary Syndrome and Nutrition, run by University Hospital A Coruña at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03234023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.