Coronary (Artery); DiseaseFAMOUSNCT03040700
Follow-up of Patients With Multivessel Coronary Artery Disease After CABG
A study testing Myocardial Perfusion Scan and Coronary CTA in people with Coronary (Artery); Disease, run by Ministry of Health, Brazil at 1 site in Brazil.
Trial summary
The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A total of 600 patients will be included and followed for 5 years. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary (Artery); Disease
- What is being tested?
- Myocardial Perfusion Scan and Coronary CTA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to Jun 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented obstructive coronary artery disease
- Isolated, recent CABG (< 30 days from inclusion)
Who cannot join
- Concomitant, severe heart disease from other etiologies including valvular heart disease, advanced dilated cardiomyopathy, etc
- Glomerular filtration rate < 30mL/min/1.73m2
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute
São Paulo, São Paulo, 05403-000
Luis Gowdak, MD, PhD, 551126615929, luis.gowdak@incor.usp.br
Luis Henrique W Gowdak, MD, PhD
About this study
Official title: "Long-term Follow-up of Patients With Multivessel Coronary Artery Disease Undergoing CABG - Comparison Between Functional, Anatomical, or Medical Only-Based Evaluation to Prevent Cardiovascular Events - The FAMOUS Trial"
The FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A total of 600 patients will be included and followed for 5 years. Patients will be randomly allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will be followed by regular medical visits only every 6 months; patients in the functional arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms every 2 years after the first year post-surgery. The primary outcome will be the incidence of death, acute myocardial infarction or myocardial revascularization.
Read the detailed description
Background: Coronary artery disease (CAD) is a highly prevalent clinical condition, usually associated with impairment in quality of life, and with a high risk for cardiovascular events including myocardial infarction and cardiovascular death. Because of the anatomical and/or functional extension of the disease, combined with high-risk clinical features (left ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients must undergo a coronary artery bypass grafting (CABG) surgery. In the USA, 400,000 CABG surgeries are performed annually.
Although the benefits of CABG for those high-risk patients have been well established in the long-term, the best follow-up strategy after surgery is still controversial. Current guidelines generally recommend that the follow-up of patients after CABG should be based on the same strategies proposed for patients with stable angina. The investigators hypothesized that the early identification of myocardial ischemia or progression of coronary atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone for the prevention of cardiovascular events.
- Conditions
- Coronary (Artery); Disease
- Being tested
- Myocardial Perfusion Scan, Coronary CTA
- Keywords
- coronary artery disease, surgery, angina, myocardial ischemia, non-invasive testing
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial Perfusion ScanOther
Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)
Coronary CTAOther
Coronary CTA will be performed using a 320-detector scanner, 0.5 mm slice thickness, with gantry rotation of 350ms. Prior to each scan, the patient's blood pressure and heart rate will be assessed, and if the heart rate is above 70bpm, beta-blockers will be given orally. Following oral beta blocker administration, if the heart rate is still greater than 64bpm, intravenous metoprolol will be administered. A total of 70-100 mL of iodinated contrast will be administered via an automated injector at a rate of 5mL/s. All coronary CTA images will be transferred to a workstation (Vitrea FX-Vital Image) and analyzed by two experienced cardiac imagers who are blinded to all other data using a standard 18-segment coronary tree model.
| Study group | Role | What they receive |
|---|---|---|
| Clinical | No intervention | Regular medical visits every 6 months. |
| Myocardial Perfusion Scan | Experimental | Myocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole) Receives: Other: Myocardial Perfusion Scan |
| Coronary CTA | Experimental | Coronary computed tomography angiography Receives: Other: Coronary CTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite fatal/non-fatal MACE
All-cause death, non-fatal MI, or myocardial revascularization
Measured: 5 years post-CABG
Secondary outcomes (2)
Cardiovascular death
Death related to cardiovascular events including sudden death, and death due to acute coronary syndromes (unstable angina, myocardial infarction), heart failure, myocardial revascularization procedures
Measured: 1, 3, and 5 years post-CABG
Cardiovascular hospitalizations
Hospital admissions due to cardiovascular events
Measured: 1, 3, and 5 years post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startNov 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary (Artery); DiseaseStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luis Henrique W Gowdak, MD, PhD, InCor Heart Institute
- Investigators
- Luis Henrique W Gowdak, MD, PhD, Principal investigator, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040700
- Sponsor's protocol ID
- 405153/2012-0
- Acronym
- FAMOUS
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Long-term Follow-up of Patients With Multivessel Coronary Artery Disease Undergoing CABG - Comparison Between Functional, Anatomical, or Medical Only-Based Evaluation to Prevent Cardiovascular Events - The FAMOUS Trial"
- ClinicalTrials.gov ID
- NCT03040700
- Acronym / sponsor ID
- FAMOUS / 405153/2012-0
- Conditions
- Coronary (Artery); Disease
- Keywords
- coronary artery disease, surgery, angina, myocardial ischemia, non-invasive testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ministry of Health, BrazilOther government
- Study start
- Nov 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Feb 2017 (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 FAMOUS Trial is a single-center, prospective, randomized study aimed to compare three different strategies (clinical, anatomical, or functional) in preventing MACE after CABG. A total of 600 patients will be included and followed for 5 years. Patients will be randomly allocated (1:1:1) in one of the three follow-up strategies. Patients in the clinical arm will be followed by regular medical visits only every 6 months; patients in the functional arm will undergo a myocardial perfusion scan, and those in the anatomical arm will be subjected to a coronary CT. Non-invasive tests will be performed per protocol and regardless symptoms every 2 years after the first year post-surgery. The primary outcome will be the incidence of death, acute myocardial infarction or myocardial revascularization.
Detailed description
Background: Coronary artery disease (CAD) is a highly prevalent clinical condition, usually associated with impairment in quality of life, and with a high risk for cardiovascular events including myocardial infarction and cardiovascular death. Because of the anatomical and/or functional extension of the disease, combined with high-risk clinical features (left ventricular dysfunction, diabetes, or chronic kidney disease to name a few), many patients must undergo a coronary artery bypass grafting (CABG) surgery. In the USA, 400,000 CABG surgeries are performed annually.
Although the benefits of CABG for those high-risk patients have been well established in the long-term, the best follow-up strategy after surgery is still controversial. Current guidelines generally recommend that the follow-up of patients after CABG should be based on the same strategies proposed for patients with stable angina. The investigators hypothesized that the early identification of myocardial ischemia or progression of coronary atherosclerosis, even in asymptomatic patients, may be superior to clinical follow-up alone for the prevention of cardiovascular events.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical | No intervention | –Regular medical visits every 6 months. |
| Myocardial Perfusion Scan | Experimental | Other: Myocardial Perfusion ScanMyocardial perfusion stress test using cardiac scintigraphy (Sestamibi) at rest and during pharmacological stress (dipyridamole) |
| Coronary CTA | Experimental | Other: Coronary CTACoronary computed tomography angiography |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented obstructive coronary artery disease
- Isolated, recent CABG (< 30 days from inclusion)
Key exclusion criteria (2 listed)
- Concomitant, severe heart disease from other etiologies including valvular heart disease, advanced dilated cardiomyopathy, etc
- Glomerular filtration rate < 30mL/min/1.73m2
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 |
|---|---|---|
| Myocardial Perfusion ScanMyocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi) | Other | Myocardial Perfusion Scan |
| Coronary CTACoronary CTA will be performed using a 320-detector scanner, 0.5 mm slice thickness, with gantry rotation of 350ms. Prior to each scan, the patient's blood pressure and heart rate will be assessed, and if the heart rate is above 70bpm, beta-blockers will be given orally. Following oral beta blocker administration, if the heart rate is still greater than 64bpm, intravenous metoprolol will be administered. A total of 70-100 mL of iodinated contrast will be administered via an automated injector at a rate of 5mL/s. All coronary CTA images will be transferred to a workstation (Vitrea FX-Vital Image) and analyzed by two experienced cardiac imagers who are blinded to all other data using a standard 18-segment coronary tree model. | Other | Coronary CTA |
Primary outcome
Composite fatal/non-fatal MACE
Time frame: 5 years post-CABG
All-cause death, non-fatal MI, or myocardial revascularization
2 secondary outcomes
Cardiovascular death
Time frame: 1, 3, and 5 years post-CABG
Cardiovascular hospitalizations
Time frame: 1, 3, and 5 years post-CABG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Luis Henrique W Gowdak, MD, PhD principal investigator
Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myocardial Perfusion Scan and Coronary CTA in people with Coronary (Artery); Disease, run by Ministry of Health, Brazil at 1 site in Brazil.
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 2 inclusion and 2 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 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 Priscila B Miagui, Pharma D (55-11-2661-5573, gestaodeprojetoslgcm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite fatal/non-fatal MACE (time frame: 5 years post-CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2017.