COVID-19 PandemicNCT05715879
Covid-19 Infection and Long-term Cardiovascular Symptoms
An observational study of COVID-19 Pandemic and Dyspnea; Cardiac, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
From the registry of professor Kojuri clinic , those with Covid-19 infection were selected and was contacted and asked about the cardiovascular symptoms, 1 year after the covid infection Read more about this study
- Who is it for?
- Ages 15 to 78 years
- Conditions the study is for
- COVID-19 Pandemic, Dyspnea; Cardiac, Chest Syndrome
- What is being tested?
- covid infection and admission to hispital
- How many people
- 879 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2020to 1 May 2021
- How long will I take part?
- 365 Days
- Phase
- Observational
- 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 15 to 78 years
- All sexes
- Child, Adult, Older adult
Study population: The study population was patients referring to Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email: kojurij@yahoo.com, webpage: http://kojuriclinic.com). A database of patients' information is available, including underlying diseases, signs and symptoms, medications, laboratory tests, electrocardiography, and echocardiography. The data is documented by expert cardiologists on every patient's visit.
Who may be able to join
- COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago
Who cannot join
- COVID-19 infection, which occurred less than a year ago,
- probable history of COVID-19 not confirmed by PCR or HRCT
Trial locations and contacts
1 site in 1 country.
Iran1 site
Cardiology Ward Shiraz University of Medical Sciences
Shiraz, Fars, 51318
About this study
Official title: The Long-term Effects of the Covid-19 Infection on Cardiac Symptoms, Should We Have a Realistic Concern?
From the registry of professor Kojuri clinic , those with Covid-19 infection were selected and was contacted and asked about the cardiovascular symptoms, 1 year after the covid infection
Read the detailed description
This retrospective cohort study was conducted between October 2020 to May 2021. The study population was patients referring to Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email: kojurij@yahoo.com, webpage: http://kojuriclinic.com). A database of patients' information is available, including underlying diseases, signs and symptoms, medications, laboratory tests, electrocardiography, and echocardiography. The data is documented by expert cardiologists on every patient's visit.
The inclusion criteria were having a history of COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago. The exclusion criteria were having a history of documented COVID-19 infection, which occurred less than a year ago, and having a probable history of COVID-19 not confirmed by PCR or HRCT.
Patients' information before COVID-19 infection was extracted from the database, including baseline demographic data, COVID-19 vaccination history, hypertension (HTN), dyslipidemia (or hyperlipidemia (HLP)), diabetes mellitus (DM), smoking, CVD, and prescribed medications. Patients with incomplete data before COVID-19 or with outdated data were excluded.
We contacted the enrolled patients to get informed about their symptoms, such as dyspnea at rest, dyspnea on exertion (DOE), orthopnea, paroxysmal nocturnal dyspnea (PND) 21, chest pain (CP) 22, fatigue 23, and palpitations 24. Patients were asked to rate their dyspnea at rest from 0 to 10, according to the 10-category ratio. A score of zero means no breathing discomfort, and ten indicates the most severe dyspnea. A score between 1 to 4 was considered mild, 5 to 6 moderate, and 7 to 10 severe. We also used functional class 1 to 4 to assess their dyspnea. Functional class 1 means no limitations in daily activities, functional class 2 means mild exertional dyspnea, functional class 3 indicates moderate dyspnea with daily activities, and functional class 4 figures dyspnea at rest 25. Chest pain was defined, based on the American heart association 2021, as "noncardiac," "possible cardiac," and "cardiac" 22.
A history of major adverse cardiovascular events (MACE) during a year follow-up of COVID-19 infection and admission due to COVID-19 were also reported. MACE is defined as myocardial infarction (MI), admission due to heart failure (HF), stroke, cardiac death, and revascularization procedures, including coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) 26.
HTN is defined as clinic SBP ≥140 mm Hg or DBP ≥90 mm Hg in repeated assessment 27. DM is diagnosed based on the American diabetes association (ADA) 2020 guidelines 28. Dyslipidemia is defined as abnormalities in TG, LDL, or HDL cholesterol. A TG level of more than 150 mg/dL is considered abnormal. HDL less than 40 mg/dL, LDL more than 100mg/dL, or is defined as dyslipidemia 29. Current smokers are defined as those who have smoked ≥100 cigarettes and smoked during the 30 days preceding the study. Former smokers have stopped smoking more than 30 days before the research 30.
Statistical analysis was performed using SPSS for Windows ver. 26 (IBM Corp., Armonk, NY, USA). We described continuous variables by mean ±standard deviation. Categorical variables were described by frequency and percentage. We used repeated measure ANOVA and paired-sample t-test for normal distribution variables and Wilcoxon signed-rank test for repeated categorical variables. Pearson's chi-squared test and Kruskal-Wallis test are applied to categorical data. We controlled the effects of confounding factors by using generalized linear models and repeating analyses by different subgroups. Statistical significance was indicated when P<0.05.
All patients were informed about the details of this research and provided their informed consent. Patients who declined to participate in the study were excluded
- Being tested
- covid infection, admission to hispital
- Keywords
- Atherosclerosis, covid-19, dyspnea, chest pain
- Medical subject headings
- COVID-19, Dyspnea, Atherosclerosis, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid infectionDiagnostic test
Also called covid 19 infection
patients with covid infection which was proved with positive test
admission to hispitalBiological
patients with sever covid disease, who was admitted in hospital
| Study group | Role | What they receive |
|---|---|---|
| diseased | covid infection patients Receives: Diagnostic Test: covid infection; Biological: admission to hispital |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyspnea
Abnormal shortness of breath with lower activities or at rest
Measured: 1 year
chest pain
cheat pain mimicking angina
Measured: 1 year
MACE
major adverse cardiac events, myocardial infarction, admission, death or nead for revascularization
Measured: 1 year
Secondary outcomes (1)
fatigue
feeling weakness with less than ordinary activities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Oct 2020
- Primary completion1 May 2021
- Study completion1 May 2021
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 COVID-19 PandemicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 879 participants (actual)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715879
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1401.465
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Golchin Vafa R, Heydarzadeh R, Rahmani M, Tavan A, Khoshnoud Mansorkhani S, Zamiri B, Amiri F, Azadian A, Khademolhosseini A, Montaseri M, Hosseini N, Hosseini SA, Kojuri J. The long-term effects of the Covid-19 infection on cardiac symptoms. BMC Cardiovasc Disord. 2023 Jun 6;23(1):286. doi: 10.1186/s12872-023-03322-8.
PubMed 37280530
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Effects of the Covid-19 Infection on Cardiac Symptoms, Should We Have a Realistic Concern?
- ClinicalTrials.gov ID
- NCT05715879
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1401.465
- Keywords
- Atherosclerosis, covid-19, dyspnea, chest pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 8 Feb 2023 (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.
From the registry of professor Kojuri clinic , those with Covid-19 infection were selected and was contacted and asked about the cardiovascular symptoms, 1 year after the covid infection
Detailed description
This retrospective cohort study was conducted between October 2020 to May 2021. The study population was patients referring to Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email: kojurij@yahoo.com, webpage: http://kojuriclinic.com). A database of patients' information is available, including underlying diseases, signs and symptoms, medications, laboratory tests, electrocardiography, and echocardiography. The data is documented by expert cardiologists on every patient's visit.
The inclusion criteria were having a history of COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago. The exclusion criteria were having a history of documented COVID-19 infection, which occurred less than a year ago, and having a probable history of COVID-19 not confirmed by PCR or HRCT.
Patients' information before COVID-19 infection was extracted from the database, including baseline demographic data, COVID-19 vaccination history, hypertension (HTN), dyslipidemia (or hyperlipidemia (HLP)), diabetes mellitus (DM), smoking, CVD, and prescribed medications. Patients with incomplete data before COVID-19 or with outdated data were excluded.
We contacted the enrolled patients to get informed about their symptoms, such as dyspnea at rest, dyspnea on exertion (DOE), orthopnea, paroxysmal nocturnal dyspnea (PND) 21, chest pain (CP) 22, fatigue 23, and palpitations 24. Patients were asked to rate their dyspnea at rest from 0 to 10, according to the 10-category ratio. A score of zero means no breathing discomfort, and ten indicates the most severe dyspnea. A score between 1 to 4 was considered mild, 5 to 6 moderate, and 7 to 10 severe. We also used functional class 1 to 4 to assess their dyspnea. Functional class 1 means no limitations in daily activities, functional class 2 means mild exertional dyspnea, functional class 3 indicates moderate dyspnea with daily activities, and functional class 4 figures dyspnea at rest 25. Chest pain was defined, based on the American heart association 2021, as "noncardiac," "possible cardiac," and "cardiac" 22.
A history of major adverse cardiovascular events (MACE) during a year follow-up of COVID-19 infection and admission due to COVID-19 were also reported. MACE is defined as myocardial infarction (MI), admission due to heart failure (HF), stroke, cardiac death, and revascularization procedures, including coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) 26.
HTN is defined as clinic SBP ≥140 mm Hg or DBP ≥90 mm Hg in repeated assessment 27. DM is diagnosed based on the American diabetes association (ADA) 2020 guidelines 28. Dyslipidemia is defined as abnormalities in TG, LDL, or HDL cholesterol. A TG level of more than 150 mg/dL is considered abnormal. HDL less than 40 mg/dL, LDL more than 100mg/dL, or is defined as dyslipidemia 29. Current smokers are defined as those who have smoked ≥100 cigarettes and smoked during the 30 days preceding the study. Former smokers have stopped smoking more than 30 days before the research 30.
Statistical analysis was performed using SPSS for Windows ver. 26 (IBM Corp., Armonk, NY, USA). We described continuous variables by mean ±standard deviation. Categorical variables were described by frequency and percentage. We used repeated measure ANOVA and paired-sample t-test for normal distribution variables and Wilcoxon signed-rank test for repeated categorical variables. Pearson's chi-squared test and Kruskal-Wallis test are applied to categorical data. We controlled the effects of confounding factors by using generalized linear models and repeating analyses by different subgroups. Statistical significance was indicated when P<0.05.
All patients were informed about the details of this research and provided their informed consent. Patients who declined to participate in the study were excluded
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 365 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diseased | – | Diagnostic Test: covid infection, Biological: admission to hispitalcovid infection patients |
Who may qualify
- Ages
- 15 to 78 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was patients referring to Professor Kojuri Cardiovascular Clinic in Shiraz, Iran (email: kojurij@yahoo.com, webpage: http://kojuriclinic.com). A database of patients' information is available, including underlying diseases, signs and symptoms, medications, laboratory tests, electrocardiography, and echocardiography. The data is documented by expert cardiologists on every patient's visit.
Key inclusion criteria (1 listed)
- COVID-19 infection confirmed by PCR or suggested by HRCT findings and having been afflicted with COVID-19 at least one year ago
Key exclusion criteria (2 listed)
- COVID-19 infection, which occurred less than a year ago,
- probable history of COVID-19 not confirmed by PCR or HRCT
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 |
|---|---|---|
| covid infectionAlso: covid 19 infectionpatients with covid infection which was proved with positive test | Diagnostic test | diseased |
| admission to hispitalpatients with sever covid disease, who was admitted in hospital | Biological | diseased |
Primary outcome
dyspnea
Time frame: 1 year
Abnormal shortness of breath with lower activities or at rest
chest pain
Time frame: 1 year
cheat pain mimicking angina
MACE
Time frame: 1 year
major adverse cardiac events, myocardial infarction, admission, death or nead for revascularization
1 secondary outcome
fatigue
Time frame: 1 year
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 1 May 2023.
- Derived from this study: PubMed 37280530Golchin Vafa R, Heydarzadeh R, Rahmani M, Tavan A, Khoshnoud Mansorkhani S, Zamiri B, Amiri F, Azadian A, Khademolhosseini A, Montaseri M, Hosseini N, Hosseini SA, Kojuri J. The long-term effects of the Covid-19 infection on cardiac symptoms. BMC Cardiovasc Disord. 2023 Jun 6;23(1):286. doi: 10.1186/s12872-023-03322-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Dyspnea; Cardiac, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 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: finished, as of the sponsor's last update on 1 May 2023. 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 Iran. 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?
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?
dyspnea (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT05715879, 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 1 May 2023.