Small vessel assessment to guide early hospital discharge following acute heart attack
| ISRCTN | ISRCTN56383403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56383403 |
| IRAS number | 334935 |
| Secondary identifying numbers | 10630, IRAS 334935, CPMS 59911 |
- Submission date
- 11/06/2024
- Registration date
- 05/07/2024
- Last edited
- 02/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Patients presenting with heart attack remain in hospital for 48 hours following their emergency treatment with stents. Recent UK data highlighted the safety of shorter in-hospital stays following heart attacks. Nonetheless, the decision to early discharge patients remains subjective. Index microcirculatory resistance (IMR) is a well-established wire-based technology and can directly evaluate the status of the injured heart immediately after a heart attack. It was demonstrated to be a reliable tool in predicting in-hospital complications and outperformed guidelines-recommended models in identifying patients who are susceptible to adverse outcomes whilst in hospital. IMR is strongly linked to the amount of clot inside the heart blood vessel. New technologies appear promising in reducing clot volume which could help protect the injured heart after a heart attack. The aim of this study is to evaluate the effect of using IMR to guide hospital discharge and its impact on the strength of heart muscle in patients presenting with heart attack.
Who can participate?
Patients aged 18-90 years with acute heart attack
What does the study involve?
Patients who have large clot volumes will be randomly allocated to either a new clot removal device or conventional treatment. The amount of clot will be assessed using an established imaging device and IMR will be performed at the end of the stenting procedure. Patients with favourable IMR will be randomly allocated to early or standard discharge. Patients in the standard discharge will remain in hospital according to local policy. Patients in the early discharge group will be planned for hospital discharge on the following day. Patients with unfavourable IMR will remain in-hospital according to local policy. The strength of the heart muscle is assessed by an MRI scan after 3 months. The amount of clot inside the heart blood vessel is also measured.
What are the possible benefits and risks of participating?
The benefits are identifying patients who are at low risk and suitable for early hospital discharge. The risk is related to early discharge as it is not yet standard clinical practice.
Where is the study run from?
Freeman Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2022 to December 2026
Who is funding the study?
1. Abbott Vascular (USA)
2. Vesalio (USA)
Who is the main contact?
Dr Mohammad Alkhalil, mohammad.alkhalil@nhs.net
Contact information
Public, Scientific, Principal Investigator
Cardiothoracic Department
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
 ORCID ID |
0000-0002-3088-8878 |
|---|---|
| Phone | +44 (0)191 233 6161 |
| mohammad.alkhalil@nhs.net |
Study information
| Study design | Prospective single-centre randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Safety of Early discharge Using index microcirculatory Resistance in patients with acute myocardial infarction (SECURE) |
| Study acronym | SECURE |
| Study objectives | The use of coronary physiology is a safe strategy to guide early discharge in patients presenting with ST-segment elevation myocardial infarction (STEMI) |
| Ethics approval(s) |
Approved 03/04/2024, South East Scotland Research Ethics Committee (Waverley Gate, 2-4 Waterloo Place, Edinburgh, EH1 3EG, United Kingdom; +44 (0)7814 764 241; eilidh.clifford@nhs.scot), ref: 23/SS/0116 |
| Health condition(s) or problem(s) studied | Acute myocardial infarction |
| Intervention | The aim of this study is to evaluate the effect of using index microcirculatory resistance (IMR) to guide hospital discharge and its impact on the strength of heart muscle in patients presenting with heart attack. A sub-study of patients who have large clot volume will be randomised, after obtaining verbal consent, to either a new clot removal device or conventional treatment. The amount of clot will be assessed using an established imaging device and IMR will be performed at the end of the stenting procedure. Patients with favourable IMR will be subsequently randomised using web-based randomisation into early or standard discharge. Patients in the standard discharge will remain in the hospital according to local policy. Patients in the early discharge group will be planned for hospital discharge on the following day. Patients with unfavourable IMR will remain in-hospital according to local policy. The primary endpoint of this study is the strength of the heart muscle as assessed by magnetic resonance imaging after 3 months. For the sub-study, the primary endpoint is the amount of clot inside the heart blood vessel. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure | Left ventricle function (strength of heart muscle) measured using cardiac magnetic resonance imaging.at 3 months |
| Secondary outcome measures | 1. Clinical events measured using GP/ hospital records and patient contact at 1 year 2. Clot volume during acute heart attack measured using optical coherence tomography at the time of acute heart attack presentation 3. Health status measured using Seattle questionnaire at 3 months |
| Overall study start date | 01/02/2022 |
| Completion date | 28/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 122 |
| Key inclusion criteria | Patients aged 18-90 years presenting with ST-segment elevation myocardial infarction (STEMI) |
| Key exclusion criteria | 1. Patients in whom safety or clinical concerns preclude participation 2. Pregnant or breastfeeding female 3. Suboptimal angiographic results such as final slow flow or distal embolization 4. Need for in-hospital staged percutaneous coronary intervention (PCI) 5. Cardiogenic shock 6. Pulmonary oedema or severe heart failure requiring diuretics treatment during or immediately after the procedure 7. Contraindication to adenosine 8. Standard contra-indications to MRI such as claustrophobia 9. Known allergy to any other component of xience stent |
| Date of first enrolment | 09/05/2024 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Research Office
Regent Point
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)1912825490 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 28/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authors will acknowledge that the study was funded by the appropriate funding body. Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. |
| IPD sharing plan | Data related to this study will be available from Dr Mohammad Alkhalil (mohammad.alkhalil@nhs.net) on reasonable request |
Editorial Notes
02/09/2024: Sponsor email address corrected.
02/08/2024: Internal review.
11/06/2024: Study's existence confirmed by South East Scotland Research Ethics Committee.
