Left Ventricular RemodelingIMMACULATENCT02468349
IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
A study testing Telemedicine in people with Left Ventricular Remodeling and Medication Adherence, run by National University Heart Centre, Singapore at 3 sites in Singapore.
Trial summary
The proposed research aims to compare Left ventricular remodeling outcomes among patients with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI treatment vs. non-telemedicine guided treatment. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Left Ventricular Remodeling, Medication Adherence, Acute Coronary Syndrome
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesSingapore
- Study dates
- Jun 2015to Dec 2020
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed STEMI or NSTEMI* within the last 7 days at high risk of ventricular remodeling
- Typical history of ischemic chest pain or angina equivalent symptoms (e.g. acute onset dyspnea)
- Typical rise or fall of cardiac enzymes with at least one value of cardiac troponin I≥10 ug/L.
- ECG changes required for diagnosis of STEMI: ≥0.1mV ST segment elevation in two or more contiguous limb leads or precordial leads or presence of Q waves ≥0.02 sec in two or more contiguous limb leads or precordial leads, or new onset left bundle branch block (LBBB), *The definition of STEMI and NSTEMI follows the 3rd universal definition of MI [19]
- Pre-discharge NTproBNP ≥300 pg/mL for both STEMI and NSTEMI
- Undergone PCI for the index event
- Age >21 years and <85 years
Who cannot join
- Hypersensitivity to ticagrelor, aspirin or any excipients
- Active pathological bleeding
- History of intracranial haemorrhage
- Bacterial Infection within 6 weeks preceding the primary angioplasty, HIV, autoimmune disease (e.g. SLE, rheumatoid arthritis, scleroderma and Grave's disease, etc) or on immunosuppressive therapy
- Women of child-bearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period
- Malignancy within last 2 years
Show all 18Show fewer
- History of significant valvular heart disease (moderate or severe MS, MR, AS, AR, TR)
- Planned CABG within the next 6 weeks
- Unable to be weaned off inotropes or IABP
- Active asthma or any other contraindications to beta-blockers
- Arrhythmias precluding proper CMR image acquisition, such as atrial fibrillation and frequent atrial or ventricular ectopy of > 1 in 5 intrinsic QRS complexes
- Contraindications to cardiac magnetic resonance imaging including claustrophobia, pacemaker or ICD implantation, mechanical valve or other metallic implants
- Severe liver impairment due to chronic liver disease e.g. advanced alcoholic liver cirrhosis or primary biliary cirrhosis
- Significant renal impairment (eGFR <50ml min-1), end stage renal failure on renal replacement therapy
- Anaemia (Hb<10 g/dL).
- Psychosocial barriers to telemedicine adoption (screening for education level, dementia, substance abuse and other psychological disorders)
- Participants who cannot be followed up
- Participants not able or willing to consent for study.
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, National Heart Research Institute, 169609
Derek Hausenloy, +65 65166719, d.hausenloy@ucl.ac.uk
Derek Hausenloy
- Recruiting
National University Heart Centre Singapore
Singapore, 119228
Sock Cheng Poh, +65 66015951, sock_cheng_poh@nuhs.edu.sg
Karen Koh, +65 67726884
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Tasha Mahadi, +65 63578124, tashama@ttsh.com.sg
Hee Hwa Ho
About this study
The proposed research aims to compare Left ventricular remodeling outcomes among patients with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI treatment vs. non-telemedicine guided treatment.
Read the detailed description
Acute Myocardial Infarction (AMI) accounts for more than 6,000 admissions to Singapore hospitals each year. Contemporary treatment, including percutaneous intervention (angioplasty and stenting) and adjunctive drug therapy, has reduced early mortality from AMI.
In many healthcare systems, Hospital scorecards stipulate prescription of appropriate drugs upon discharge after hospitalization for AMI. These drugs include aspirin, a platelet P2Y12 inhibitor, angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers and lipid-lowering drugs. Such quality improvement programs have led to an increase in prescription of these drugs upon discharge. Yet, 2 problems remain pervasive:
- dose optimization; how the investigators escalate patients to the most effective drug doses, and
- drug adherence; whether patients are taking these drugs regularly.
These 2 problems stem largely from the traditional model of episodic care entailing face-to-face visits between patient and healthcare practitioner. Inadequate dose optimization is most relevant to ACE-I/ARB and beta-blockers as healthcare practitioners necessarily prescribe low doses of these drugs at discharge to avoid excessive lowering of blood pressure soon after an AMI. Yet, these drugs are most effective at preventing adverse ventricular remodeling when patients take them at their maximum tolerated doses. In clinical trials, titrating these ACE-I/ARB and beta-blockers to target doses has required weekly outpatient visits, a model of care that most healthcare systems cannot afford.
The investigators hypothesize that a telemedicine-based system of care will lead to a greater reduction in ventricular remodeling as compared with usual care, by improving dose optimization and adherence to ACE-I/ARB and beta-blockers in patients with recent AMI.
Participants with AMI (n=300) will be recruited during the index hospitalization. A key inclusion criteria is an elevated NT-proBNP measurement during the index hospitalization. Participants will first undergo stratified randomization according to ST-segment classification (STEMI/NSTEMI), thereafter randomized into the Telehealth versus Control group in 1:1 sequential block randomization (blocks of 4 and 6). The telehealth intervention group will have their blood pressure and heart rate monitored twice daily at home for 2 months, with alternating titration between ACE-inhibitors and betablockers weekly during the first 2 months. After 2 months, they will continue on telemedicine consultation for 4 months; coaching on drug adherence, drug side-effects management and monitoring of symptoms. A smartphone-based app developed by PEACH Intellihealth will provide structured health education, medication reminders and real-time text messaging with telehealth professionals.
All participants enrolled will be put on 1 year of dual antiplatelet therapy, have a cardiac MRI done both at baseline and 6-months, and followed up with cardiologist review visit at 1, 6 and 12 months. Major adverse cardiovascular and cerebrovascular events will be assessed during each cardiologist review visit, and beyond 12 months, it will be assessed by either phone calls or online/mailed questionnaires at 18 and 24 months.
Four substudies have been planned: a substudy to assess the impact of telemedicine on readmissions (ALTRA), a substudy to assess the effect of telemedicine on adherence to antiplatelet therapy (TICA), a substudy to assess the cost-effectiveness of telemedicine (CEA) and a substudy to assess the effect of telemedicine on MR-PET measured cardiac work efficiency (CES).
- Being tested
- Telemedicine
- Keywords
- Acute Myocardial Infarction, Telemedicine, Readmissions
- Medical subject headings
- Ventricular Remodeling, Medication Adherence, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Participants enrolled will be randomised 1:1 to either telemedicine arm or standard care arm.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | The telehealth group will be remotely monitored and managed on medication adherence, dosage titration, and management of drug side effects, through a combination of feed-forward blood pressure monitoring, app-based education and medication reminders, and remote consultations. Receives: Other: Telemedicine |
| Standard care | No intervention | The standard care group will receive face-to-face consultations at one month, 6 months and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Left Ventricular End-Systolic Volume (ml)
Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging
Measured: 6 months
Secondary outcomes (4)
Haemodynamic Stress
Frequency of participants with reduction in NT-proBNP <20%
Measured: 6 months
Infarct size (grams and % of total LV mass)
Infarct size (grams and % of total LV mass) measured on cardiac magnetic resonance imaging
Measured: 6 months
Adenosine diphosphate-induced platelet reactivity
Difference in Multiplate ADP test (AU*min)
Measured: 6 months
Hospitalisation & readmission
Difference in incidence of Death, MI, Stroke, readmission for recurrent ischaemia requiring unplanned revascularization and readmission for heart failure.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular RemodelingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Heart Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore, National University Hospital, Singapore, Tan Tock Seng Hospital
- Responsible party
- Principal investigator, Mark Chan, National University Heart Centre, Singapore
- Investigators
- Mark Chan, Principal investigator, National University Heart Centre, SingaporeA. Mark Richards, Study chair, National University Heart Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468349
- Sponsor's protocol ID
- 2014/00793
- Other IDs
- 2014
- Acronym
- IMMACULATE
- Status last verified
- Mar 2018
- First submitted
- 7 Jun 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arnold SV, Spertus JA, Masoudi FA, Daugherty SL, Maddox TM, Li Y, Dodson JA, Chan PS. Beyond medication prescription as performance measures: optimal secondary prevention medication dosing after acute myocardial infarction. J Am Coll Cardiol. 2013 Nov 5;62(19):1791-801. doi: 10.1016/j.jacc.2013.04.102. Epub 2013 Aug 21.
PubMed 23973701Chan MY, Koh KWL, Poh SC, Marchesseau S, Singh D, Han Y, Ng F, Lim E, Prabath JF, Lee CH, Sim HW, Chen R, Carvalho L, Tan SH, Loh JPY, Tan JWC, Kuwelker K, Amanullah RM, Chin CT, Yip JWL, Lee CY, Gan J, Lo CY, Ho HH, Hausenloy DJ, Tai BC, Richards AM; IMMACULATE Investigators. Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care: The IMMACULATE Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):830-835. doi: 10.1001/jamacardio.2020.6721.
PubMed 33377898
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMproving reModeling in Acute myoCardial Infarction Using Live and Asynchronous TElemedicine.
- ClinicalTrials.gov ID
- NCT02468349
- Acronym / sponsor ID
- IMMACULATE / 2014/00793
- Keywords
- Acute Myocardial Infarction, Telemedicine, Readmissions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National University Heart Centre, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore, National University Hospital, Singapore, Tan Tock Seng Hospital
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jun 2015 (estimated)
- 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.
The proposed research aims to compare Left ventricular remodeling outcomes among patients with AMI and elevated NT-pro-B-type natriuretic peptide receiving telemedicine-guided post-MI treatment vs. non-telemedicine guided treatment.
Detailed description
Acute Myocardial Infarction (AMI) accounts for more than 6,000 admissions to Singapore hospitals each year. Contemporary treatment, including percutaneous intervention (angioplasty and stenting) and adjunctive drug therapy, has reduced early mortality from AMI.
In many healthcare systems, Hospital scorecards stipulate prescription of appropriate drugs upon discharge after hospitalization for AMI. These drugs include aspirin, a platelet P2Y12 inhibitor, angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers and lipid-lowering drugs. Such quality improvement programs have led to an increase in prescription of these drugs upon discharge. Yet, 2 problems remain pervasive:
- dose optimization; how the investigators escalate patients to the most effective drug doses, and
- drug adherence; whether patients are taking these drugs regularly.
These 2 problems stem largely from the traditional model of episodic care entailing face-to-face visits between patient and healthcare practitioner. Inadequate dose optimization is most relevant to ACE-I/ARB and beta-blockers as healthcare practitioners necessarily prescribe low doses of these drugs at discharge to avoid excessive lowering of blood pressure soon after an AMI. Yet, these drugs are most effective at preventing adverse ventricular remodeling when patients take them at their maximum tolerated doses. In clinical trials, titrating these ACE-I/ARB and beta-blockers to target doses has required weekly outpatient visits, a model of care that most healthcare systems cannot afford.
The investigators hypothesize that a telemedicine-based system of care will lead to a greater reduction in ventricular remodeling as compared with usual care, by improving dose optimization and adherence to ACE-I/ARB and beta-blockers in patients with recent AMI.
Participants with AMI (n=300) will be recruited during the index hospitalization. A key inclusion criteria is an elevated NT-proBNP measurement during the index hospitalization. Participants will first undergo stratified randomization according to ST-segment classification (STEMI/NSTEMI), thereafter randomized into the Telehealth versus Control group in 1:1 sequential block randomization (blocks of 4 and 6). The telehealth intervention group will have their blood pressure and heart rate monitored twice daily at home for 2 months, with alternating titration between ACE-inhibitors and betablockers weekly during the first 2 months. After 2 months, they will continue on telemedicine consultation for 4 months; coaching on drug adherence, drug side-effects management and monitoring of symptoms. A smartphone-based app developed by PEACH Intellihealth will provide structured health education, medication reminders and real-time text messaging with telehealth professionals.
All participants enrolled will be put on 1 year of dual antiplatelet therapy, have a cardiac MRI done both at baseline and 6-months, and followed up with cardiologist review visit at 1, 6 and 12 months. Major adverse cardiovascular and cerebrovascular events will be assessed during each cardiologist review visit, and beyond 12 months, it will be assessed by either phone calls or online/mailed questionnaires at 18 and 24 months.
Four substudies have been planned: a substudy to assess the impact of telemedicine on readmissions (ALTRA), a substudy to assess the effect of telemedicine on adherence to antiplatelet therapy (TICA), a substudy to assess the cost-effectiveness of telemedicine (CEA) and a substudy to assess the effect of telemedicine on MR-PET measured cardiac work efficiency (CES).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicineThe telehealth group will be remotely monitored and managed on medication adherence, dosage titration, and management of drug side effects, through a combination of feed-forward blood pressure monitoring, app-based education and medication reminders, and remote consultations. |
| Standard care | No intervention | –The standard care group will receive face-to-face consultations at one month, 6 months and 12 months. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically diagnosed STEMI or NSTEMI* within the last 7 days at high risk of ventricular remodeling
- Pre-discharge NTproBNP ≥300 pg/mL for both STEMI and NSTEMI
- Undergone PCI for the index event
- Age >21 years and <85 years
Key exclusion criteria (18 listed)
- Hypersensitivity to ticagrelor, aspirin or any excipients
- Active pathological bleeding
- History of intracranial haemorrhage
- Bacterial Infection within 6 weeks preceding the primary angioplasty, HIV, autoimmune disease (e.g. SLE, rheumatoid arthritis, scleroderma and Grave's disease, etc) or on immunosuppressive therapy
- Women of child-bearing potential, known to be pregnant, breast-feeding, or intend to become pregnant during the study period
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 |
|---|---|---|
| TelemedicineParticipants enrolled will be randomised 1:1 to either telemedicine arm or standard care arm. | Other | Telemedicine |
Primary outcome
Difference in Left Ventricular End-Systolic Volume (ml)
Time frame: 6 months
Difference in Left Ventricular End-Systolic Volume (ml) measured on cardiac magnetic resonance imaging
4 secondary outcomes
Haemodynamic Stress
Time frame: 6 months
Infarct size (grams and % of total LV mass)
Time frame: 6 months
Adenosine diphosphate-induced platelet reactivity
Time frame: 6 months
Hospitalisation & readmission
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 23973701Arnold SV, Spertus JA, Masoudi FA, Daugherty SL, Maddox TM, Li Y, Dodson JA, Chan PS. Beyond medication prescription as performance measures: optimal secondary prevention medication dosing after acute myocardial infarction. J Am Coll Cardiol. 2013 Nov 5;62(19):1791-801. doi: 10.1016/j.jacc.2013.04.102. Epub 2013 Aug 21.
- Derived from this study: PubMed 33377898Chan MY, Koh KWL, Poh SC, Marchesseau S, Singh D, Han Y, Ng F, Lim E, Prabath JF, Lee CH, Sim HW, Chen R, Carvalho L, Tan SH, Loh JPY, Tan JWC, Kuwelker K, Amanullah RM, Chin CT, Yip JWL, Lee CY, Gan J, Lo CY, Ho HH, Hausenloy DJ, Tai BC, Richards AM; IMMACULATE Investigators. Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care: The IMMACULATE Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):830-835. doi: 10.1001/jamacardio.2020.6721.
- Individual participant dataSharing planned: No
Related trials for Left Ventricular Remodeling
RecruitingPhase 4
STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure
Heart Failure With Reduced Ejection Fraction, Heart Failure
RecruitingObservational study
Cold-Region Exposure and Cardiac Remodeling After PCI
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Congestive Heart Failure
Enrolling by invitationObservational study
EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study
Abdominal Aortic Aneurysm, Arterial Stiffness
RecruitingPhase 3
The Effect of Sacubitril/Valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients With Ischemic Heart Failure With Mid-range Ejection Fraction
Heart Failure With Moderately Reduced Ejection Fraction
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.
Mark Chan principal investigator
National University Heart Centre, Singapore
A. Mark Richards study chair
National University Heart Centre, Singapore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Left Ventricular Remodeling and Medication Adherence, run by National University Heart Centre, Singapore at 3 sites in Singapore.
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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sock Cheng Poh (+65 9772 0495, sock_cheng_poh@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Left Ventricular End-Systolic Volume (ml) (time frame: 6 months). 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 NCT02468349, which also lists 2 linked publications.
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 29 Mar 2018.