Acute Coronary SyndromePhase 4MOSCANCT01645943
Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities
A Phase 4 study testing Coronary angiogram in people with Acute Coronary Syndrome, run by University of Valencia at 6 sites in Spain.
Trial summary
The guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Coronary angiogram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 6 sitesSpain
- Study dates
- Jan 2012to Mar 2015
- Phase
- Phase 4
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age =>70 years old
- Angina chest pain
- Troponin elevation
- At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR <45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold>2 or ambulatory oxigen therapy). Anemia (Hb =<11 g/dl)
Who cannot join
- Dynamic ST changes (=>1 mm) in the initial ECG
- Prior known non-revascularizable coronay disease
- Concomitant heart disease different to coronary disease
- Life expentancy < 1 year
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Pujol i Trias
Badalona, Barcelona
Hopsital Clinic
Barcelona, Barcelona
Hospital Valle Hebrón
Barcelona
Hospital Virgen del Rosell
Cartagena, Murcia
Hospital Virgen Arrixaca
Murcia
Hospital Clínico Universitario
Valencia, Valencia, 460140
About this study
Official title: Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities
The guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.
Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities, will be included. The latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. The included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. All patients will receive medical treatment according to current recommendations.
The main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients with NSTEACS and comorbidities.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Coronary angiogram
- Keywords
- Non-ST-elevation acute myocardial infarction, Comorbidities
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiogramProcedure or surgery
Routine coronary angiogram and revascularization if indicated
| Study group | Role | What they receive |
|---|---|---|
| Conservative | No intervention | Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed |
| Invasive | Active comparator | Routine coronary angiogram Receives: Procedure: Coronary angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, reinfarction or reasmission by cardiac cause
Measured: 1 year
Secondary outcomes (3)
Days alive out of the hospital
Measured: 1 year
Bleeding
Measured: In-hospital (average= 1 week)
Renal failure
Measured: In-hospital (average= 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionMar 2015
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.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Juan Sanchis, University of Valencia
- Investigators
- Juan Sanchis, Full Prof, Principal investigator, University of Valencia. University Clinic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645943
- Sponsor's protocol ID
- 11/ 01595
- Acronym
- MOSCA
- Status last verified
- Oct 2016
- First submitted
- 13 Jul 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sanchis J, Nunez E, Barrabes JA, Marin F, Consuegra-Sanchez L, Ventura S, Valero E, Roque M, Bayes-Genis A, Del Blanco BG, Degano I, Nunez J. Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST elevation myocardial infarction. Eur J Intern Med. 2016 Nov;35:89-94. doi: 10.1016/j.ejim.2016.07.003. Epub 2016 Aug 8.
PubMed 27423981
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities
- ClinicalTrials.gov ID
- NCT01645943
- Acronym / sponsor ID
- MOSCA / 11/ 01595
- Conditions
- Acute Coronary Syndrome
- Keywords
- Non-ST-elevation acute myocardial infarction, Comorbidities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Jul 2012 (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 guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities.
Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities, will be included. The latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. The included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. All patients will receive medical treatment according to current recommendations.
The main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients with NSTEACS and comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | No intervention | –Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed |
| Invasive | Active comparator | Procedure: Coronary angiogramRoutine coronary angiogram |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age =>70 years old
- Angina chest pain
- Troponin elevation
- At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR <45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold>2 or ambulatory oxigen therapy). Anemia (Hb =<11 g/dl)
Key exclusion criteria (4 listed)
- Dynamic ST changes (=>1 mm) in the initial ECG
- Prior known non-revascularizable coronay disease
- Concomitant heart disease different to coronary disease
- Life expentancy < 1 year
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 |
|---|---|---|
| Coronary angiogramRoutine coronary angiogram and revascularization if indicated | Procedure or surgery | Invasive |
Primary outcome
All cause mortality, reinfarction or reasmission by cardiac cause
Time frame: 1 year
3 secondary outcomes
Days alive out of the hospital
Time frame: 1 year
Bleeding
Time frame: In-hospital (average= 1 week)
Renal failure
Time frame: In-hospital (average= 1 week)
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 26 Oct 2016.
- Results publication: PubMed 27423981Sanchis J, Nunez E, Barrabes JA, Marin F, Consuegra-Sanchez L, Ventura S, Valero E, Roque M, Bayes-Genis A, Del Blanco BG, Degano I, Nunez J. Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST elevation myocardial infarction. Eur J Intern Med. 2016 Nov;35:89-94. doi: 10.1016/j.ejim.2016.07.003. Epub 2016 Aug 8.
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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.
Juan Sanchis, Full Prof principal investigator
University of Valencia. University Clinic Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coronary angiogram in people with Acute Coronary Syndrome, run by University of Valencia at 6 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 4 inclusion and 4 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
All cause mortality, reinfarction or reasmission by cardiac cause (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 NCT01645943, 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 26 Oct 2016.