Actue Coronary SyndromeCLEAR-AMINCT06716177
Clinical Features and Linked mEchanisms in Acute Risk-free AMI
An observational study of Actue Coronary Syndrome, run by Beijing Anzhen Hospital.
Trial summary
This study aims to investigate the clinical characteristics and underlying mechanisms of acute myocardial infarction (AMI) in patients without traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, or smoking history. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actue Coronary Syndrome
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients diagnosed with acute myocardial infarction (AMI) who lack traditional cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, and obesity. These patients are recruited from a single-center or multicenter setting, such as hospitals with advanced cardiac care facilities. The population represents a unique subset of AMI patients, often underexplored in existing research. Comprehensive data, including demographic information, clinical presentations, imaging findings, laboratory biomarkers, and genetic profiles, will be collected to investigate novel risk factors and pathophysiological mechanisms contributing to AMI in this group. The study seeks to provide a detailed understanding of the characteristics and etiology of AMI in this nontraditional population.
Who may be able to join
- Patients diagnosed with acute myocardial infarction (AMI) based on standard clinical criteria (e.g., troponin elevation, ischemic symptoms, or imaging evidence of myocardial injury).
- Absence of traditional cardiovascular risk factors, including hypertension, diabetes, dyslipidemia, smoking, or obesity (BMI < 30 kg/m²).
- Aged 18 years or older. Willing and able to provide informed consent.
Who cannot join
- Presence of any traditional cardiovascular risk factors as defined above. History of known congenital or structural heart disease. Severe systemic diseases that could independently contribute to AMI (e.g., severe infection, malignancy, or autoimmune disorders).
- Recent history of major surgery or trauma within the last 3 months. Pregnancy or lactation. Inability to provide informed consent due to cognitive impairment or other reasons.
- Participation in another interventional clinical trial that might interfere with study outcomes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Features and Mechanisms of Acute Myocardial Infarction in Patients Without Traditional Cardiovascular Risk Factors
This study aims to investigate the clinical characteristics and underlying mechanisms of acute myocardial infarction (AMI) in patients without traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, or smoking history. By analyzing clinical data, imaging findings, and biomarkers, the research seeks to identify novel risk factors and mechanisms contributing to the pathogenesis of AMI in this unique population. The findings are expected to provide insights into improving diagnostic strategies and developing
Read the detailed description
Acute myocardial infarction (AMI) is a leading cause of morbidity and mortality worldwide, primarily associated with well-established cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, and obesity. However, a subset of AMI patients present without these traditional risk factors, posing a diagnostic and therapeutic challenge. This study focuses on the clinical characteristics, pathophysiological mechanisms, and potential novel risk factors associated with AMI in patients who lack conventional cardiovascular risk profiles.
The study will be conducted as a single-center observational analysis involving patients diagnosed with AMI but without a history of hypertension, diabetes, dyslipidemia, smoking, or significant family history of coronary artery disease. Key objectives include:
Characterizing Clinical Features: Analyzing demographic, clinical, and imaging data to identify patterns unique to this patient population.
Identifying Biomarkers: Exploring circulating biomarkers, including inflammatory markers, genetic predispositions, and coagulation abnormalities, that may contribute to AMI development.
Understanding Mechanisms: Investigating potential mechanisms such as microvascular dysfunction, endothelial injury, and autoimmune or hypercoagulable states.
The study will utilize advanced imaging techniques, including coronary computed tomography angiography (CTA) and cardiac magnetic resonance imaging (CMR), to assess coronary anatomy and myocardial tissue characteristics. Genomic and proteomic analyses will be performed to identify genetic and molecular contributors.
By elucidating the clinical and mechanistic profile of AMI in this unique population, the research aims to enhance the understanding of nontraditional pathways leading to AMI. These findings will pave the way for improved diagnostic tools, risk stratification models, and novel therapeutic interventions tailored to this underexplored patient group.
- Conditions
- Actue Coronary Syndrome
- Keywords
- Acute Coronary Syndromes, Risk factor, Multi-omics analysis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Without Traditional Cardiovascular Risk Factors Experiencing AMI | This cohort includes patients diagnosed with acute myocardial infarction (AMI) who do not exhibit traditional cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, or obesity. Participants will undergo comprehensive clinical assessments, including advanced imaging (coronary computed tomography angiography and cardiac magnetic resonance imaging), biomarker profiling, and genetic analyses. No direct therapeutic interventions will be applied as part of this study; instead, observational methods will be used to analyze clinical characteristics, identify novel biomarkers, and explore mechanisms contributing to AMI pathogenesis in this population. Data collected from this cohort will provide insights into the unique features and risk profiles of AMI patients without conventional risk factors, potentially informing future diagnostic and therapeutic strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Myocardial Infarction (AMI) Without Traditional Cardiovascular Risk Factors
The primary outcome measure is the identification and characterization of acute myocardial infarction (AMI) cases occurring in patients who lack traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, smoking, or obesity. The outcome will be evaluated by analyzing clinical presentation, laboratory biomarkers, imaging findings, and other diagnostic criteria to confirm the occurrence of AMI and its distinct features in this unique patient population. This will be assessed at the time of diagnosis and through follow-up evaluations during the study period.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Actue Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayi Yi, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716177
- Sponsor's protocol ID
- KS2024119
- Acronym
- CLEAR-AMI
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shamaki GR, Safiriyu I, Kesiena O, Mbachi C, Anyanwu M, Zahid S, Rai D, Bob-Manuel T, Corteville D, Alweis R, Batchelor WB. Prevalence and Outcomes in STEMI Patients Without Standard Modifiable Cardiovascular Risk Factors: A National Inpatient Sample Analysis. Curr Probl Cardiol. 2022 Nov;47(11):101343. doi: 10.1016/j.cpcardiol.2022.101343. Epub 2022 Aug 5.
PubMed 35934021Vernon ST, Coffey S, D'Souza M, Chow CK, Kilian J, Hyun K, Shaw JA, Adams M, Roberts-Thomson P, Brieger D, Figtree GA. ST-Segment-Elevation Myocardial Infarction (STEMI) Patients Without Standard Modifiable Cardiovascular Risk Factors-How Common Are They, and What Are Their Outcomes? J Am Heart Assoc. 2019 Nov 5;8(21):e013296. doi: 10.1161/JAHA.119.013296. Epub 2019 Nov 1.
PubMed 31672080Anderson JL, Knight S, May HT, Le VT, Almajed J, Bair TL, Knowlton KU, Muhlestein JB. Cardiovascular Outcomes of ST-Elevation Myocardial Infarction (STEMI) Patients without Standard Modifiable Risk Factors (SMuRF-Less): The Intermountain Healthcare Experience. J Clin Med. 2022 Dec 22;12(1):75. doi: 10.3390/jcm12010075.
PubMed 36614876Chandrashekhar Y, Alexander T, Mullasari A, Kumbhani DJ, Alam S, Alexanderson E, Bachani D, Wilhelmus Badenhorst JC, Baliga R, Bax JJ, Bhatt DL, Bossone E, Botelho R, Chakraborthy RN, Chazal RA, Dhaliwal RS, Gamra H, Harikrishnan SP, Jeilan M, Kettles DI, Mehta S, Mohanan PP, Kurt Naber C, Naik N, Ntsekhe M, Otieno HA, Pais P, Pineiro DJ, Prabhakaran D, Reddy KS, Redha M, Roy A, Sharma M, Shor R, Adriaan Snyders F, Weii Chieh Tan J, Valentine CM, Wilson BH, Yusuf S, Narula J. Resource and Infrastructure-Appropriate Management of ST-Segment Elevation Myocardial Infarction in Low- and Middle-Income Countries. Circulation. 2020 Jun 16;141(24):2004-2025. doi: 10.1161/CIRCULATIONAHA.119.041297. Epub 2020 Jun 15.
PubMed 32539609Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.
PubMed 33309175
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Mechanisms of Acute Myocardial Infarction in Patients Without Traditional Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT06716177
- Acronym / sponsor ID
- CLEAR-AMI / KS2024119
- Conditions
- Actue Coronary Syndrome
- Keywords
- Acute Coronary Syndromes, Risk factor, Multi-omics analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 4 Dec 2024 (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.
This study aims to investigate the clinical characteristics and underlying mechanisms of acute myocardial infarction (AMI) in patients without traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, or smoking history. By analyzing clinical data, imaging findings, and biomarkers, the research seeks to identify novel risk factors and mechanisms contributing to the pathogenesis of AMI in this unique population. The findings are expected to provide insights into improving diagnostic strategies and developing
Detailed description
Acute myocardial infarction (AMI) is a leading cause of morbidity and mortality worldwide, primarily associated with well-established cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, and obesity. However, a subset of AMI patients present without these traditional risk factors, posing a diagnostic and therapeutic challenge. This study focuses on the clinical characteristics, pathophysiological mechanisms, and potential novel risk factors associated with AMI in patients who lack conventional cardiovascular risk profiles.
The study will be conducted as a single-center observational analysis involving patients diagnosed with AMI but without a history of hypertension, diabetes, dyslipidemia, smoking, or significant family history of coronary artery disease. Key objectives include:
Characterizing Clinical Features: Analyzing demographic, clinical, and imaging data to identify patterns unique to this patient population.
Identifying Biomarkers: Exploring circulating biomarkers, including inflammatory markers, genetic predispositions, and coagulation abnormalities, that may contribute to AMI development.
Understanding Mechanisms: Investigating potential mechanisms such as microvascular dysfunction, endothelial injury, and autoimmune or hypercoagulable states.
The study will utilize advanced imaging techniques, including coronary computed tomography angiography (CTA) and cardiac magnetic resonance imaging (CMR), to assess coronary anatomy and myocardial tissue characteristics. Genomic and proteomic analyses will be performed to identify genetic and molecular contributors.
By elucidating the clinical and mechanistic profile of AMI in this unique population, the research aims to enhance the understanding of nontraditional pathways leading to AMI. These findings will pave the way for improved diagnostic tools, risk stratification models, and novel therapeutic interventions tailored to this underexplored patient group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Without Traditional Cardiovascular Risk Factors Experiencing AMI | – | –This cohort includes patients diagnosed with acute myocardial infarction (AMI) who do not exhibit traditional cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, or obesity. Participants will undergo comprehensive clinical assessments, including advanced imaging (coronary computed tomography angiography and cardiac magnetic resonance imaging), biomarker profiling, and genetic analyses. No direct therapeutic interventions will be applied as part of this study; instead, observational methods will be used to analyze clinical characteristics, identify novel biomarkers, and explore mechanisms contributing to AMI pathogenesis in this population. Data collected from this cohort will provide insights into the unique features and risk profiles of AMI patients without conventional risk factors, potentially informing future diagnostic and therapeutic strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients diagnosed with acute myocardial infarction (AMI) who lack traditional cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, and obesity. These patients are recruited from a single-center or multicenter setting, such as hospitals with advanced cardiac care facilities. The population represents a unique subset of AMI patients, often underexplored in existing research. Comprehensive data, including demographic information, clinical presentations, imaging findings, laboratory biomarkers, and genetic profiles, will be collected to investigate novel risk factors and pathophysiological mechanisms contributing to AMI in this group. The study seeks to provide a detailed understanding of the characteristics and etiology of AMI in this nontraditional population.
Key inclusion criteria (3 listed)
- Patients diagnosed with acute myocardial infarction (AMI) based on standard clinical criteria (e.g., troponin elevation, ischemic symptoms, or imaging evidence of myocardial injury).
- Absence of traditional cardiovascular risk factors, including hypertension, diabetes, dyslipidemia, smoking, or obesity (BMI < 30 kg/m²).
- Aged 18 years or older. Willing and able to provide informed consent.
Key exclusion criteria (3 listed)
- Presence of any traditional cardiovascular risk factors as defined above. History of known congenital or structural heart disease. Severe systemic diseases that could independently contribute to AMI (e.g., severe infection, malignancy, or autoimmune disorders).
- Recent history of major surgery or trauma within the last 3 months. Pregnancy or lactation. Inability to provide informed consent due to cognitive impairment or other reasons.
- Participation in another interventional clinical trial that might interfere with study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Acute Myocardial Infarction (AMI) Without Traditional Cardiovascular Risk Factors
Time frame: 5 years
The primary outcome measure is the identification and characterization of acute myocardial infarction (AMI) cases occurring in patients who lack traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, smoking, or obesity. The outcome will be evaluated by analyzing clinical presentation, laboratory biomarkers, imaging findings, and other diagnostic criteria to confirm the occurrence of AMI and its distinct features in this unique patient population. This will be assessed at the time of diagnosis and through follow-up evaluations during the study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Results publication: PubMed 35934021Shamaki GR, Safiriyu I, Kesiena O, Mbachi C, Anyanwu M, Zahid S, Rai D, Bob-Manuel T, Corteville D, Alweis R, Batchelor WB. Prevalence and Outcomes in STEMI Patients Without Standard Modifiable Cardiovascular Risk Factors: A National Inpatient Sample Analysis. Curr Probl Cardiol. 2022 Nov;47(11):101343. doi: 10.1016/j.cpcardiol.2022.101343. Epub 2022 Aug 5.
- Results publication: PubMed 31672080Vernon ST, Coffey S, D'Souza M, Chow CK, Kilian J, Hyun K, Shaw JA, Adams M, Roberts-Thomson P, Brieger D, Figtree GA. ST-Segment-Elevation Myocardial Infarction (STEMI) Patients Without Standard Modifiable Cardiovascular Risk Factors-How Common Are They, and What Are Their Outcomes? J Am Heart Assoc. 2019 Nov 5;8(21):e013296. doi: 10.1161/JAHA.119.013296. Epub 2019 Nov 1.
- Results publication: PubMed 36614876Anderson JL, Knight S, May HT, Le VT, Almajed J, Bair TL, Knowlton KU, Muhlestein JB. Cardiovascular Outcomes of ST-Elevation Myocardial Infarction (STEMI) Patients without Standard Modifiable Risk Factors (SMuRF-Less): The Intermountain Healthcare Experience. J Clin Med. 2022 Dec 22;12(1):75. doi: 10.3390/jcm12010075.
- Results publication: PubMed 32539609Chandrashekhar Y, Alexander T, Mullasari A, Kumbhani DJ, Alam S, Alexanderson E, Bachani D, Wilhelmus Badenhorst JC, Baliga R, Bax JJ, Bhatt DL, Bossone E, Botelho R, Chakraborthy RN, Chazal RA, Dhaliwal RS, Gamra H, Harikrishnan SP, Jeilan M, Kettles DI, Mehta S, Mohanan PP, Kurt Naber C, Naik N, Ntsekhe M, Otieno HA, Pais P, Pineiro DJ, Prabhakaran D, Reddy KS, Redha M, Roy A, Sharma M, Shor R, Adriaan Snyders F, Weii Chieh Tan J, Valentine CM, Wilson BH, Yusuf S, Narula J. Resource and Infrastructure-Appropriate Management of ST-Segment Elevation Myocardial Infarction in Low- and Middle-Income Countries. Circulation. 2020 Jun 16;141(24):2004-2025. doi: 10.1161/CIRCULATIONAHA.119.041297. Epub 2020 Jun 15.
- Results publication: PubMed 33309175Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Actue Coronary Syndrome, run by Beijing Anzhen Hospital.
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 3 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: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayi Dr. Yi (8615810911931, yjy_adm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Myocardial Infarction (AMI) Without Traditional Cardiovascular Risk Factors (time frame: 5 years). 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 NCT06716177, which also lists 5 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 4 Dec 2024.