Cardiovascular Diseases in PregnancyPRESAPNCT06004544
Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women
An observational study of Cardiovascular Diseases in Pregnancy, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed. Ejection fraction (EF) was quantified using biplane Simpson's method. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cardiovascular Diseases in Pregnancy
- How many people
- 10,000 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Feb 2023to 31 Dec 2028
- How long will I take part?
- 1 Year
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive obstetric patients attending routine antenatal visits
Who may be able to join
- Obstetric patients attending routine antenatal visits
Who cannot join
- Patients refused to give consent for echocardiography or participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
National Institute of Cardiovascular Diseases (NICVD)
Karachi, Sindh, 75510
Sabha Bhatti, MD
Sumyia Gurmani, FCPS
About this study
Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed. Ejection fraction (EF) was quantified using biplane Simpson's method.
Read the detailed description
Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed, including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left ventricular (LV) function was quantified using biplane Simpson's method and visually assessed by two independent readers. Patients with significant valve disease or congenital heart disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and long-term follow-up.
- Conditions
- Cardiovascular Diseases in Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants found to have abnormal left ventricular function
Prevalence of Left ventricular dysfunction (Ejection Fraction<55%)
Measured: At the time of screening echocardiogram
Number of participants found to have abnormal heart valve function
Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)
Measured: At the time of screening echocardiogram
Secondary outcomes (2)
Number of participants found to have adverse Maternal outcomes
Maternal Mortality, Cardiogenic shock
Measured: At the time of delivery
Number of participants found to have adverse Fetal outcomes
Infant Mortality, Infant birth weight (kg)
Measured: At the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start6 Feb 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Cardiovascular Diseases in PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre
- Responsible party
- Principal investigator, Sabha Bhatti, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Sabha Bhatti, MD, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004544
- Sponsor's protocol ID
- IRB-33/2023
- Acronym
- PRESAP
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhatti S, Naz S, Gurmani S, Yasmin H, Atif U, Karim M, Ahmed S, Zehra K, Hakeem A, Qamar N. Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women. JACC Adv. 2024 Sep 2;3(12):101215. doi: 10.1016/j.jacadv.2024.101215. eCollection 2024 Dec.
PubMed 39817089
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women
- ClinicalTrials.gov ID
- NCT06004544
- Acronym / sponsor ID
- PRESAP / IRB-33/2023
- Conditions
- Cardiovascular Diseases in Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Aug 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.
Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed. Ejection fraction (EF) was quantified using biplane Simpson's method.
Detailed description
Consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. A standardized 2D transthoracic echocardiogram (TTE) protocol was employed, including parasternal long and short, apical 4- and 2-chamber views. Continuous wave and pulse wave Doppler were used to assess left ventricular outflow tract (LVOT) gradients. Left ventricular (LV) function was quantified using biplane Simpson's method and visually assessed by two independent readers. Patients with significant valve disease or congenital heart disease underwent complete TTE. Those diagnosed with LV dysfunction or other cardiovascular diseases (CVD) were referred to the Cardio-Obstetrics clinic for further management and long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive obstetric patients attending routine antenatal visits
Key inclusion criteria (1 listed)
- Obstetric patients attending routine antenatal visits
Key exclusion criteria (1 listed)
- Patients refused to give consent for echocardiography or participation in the study
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
Number of participants found to have abnormal left ventricular function
Time frame: At the time of screening echocardiogram
Prevalence of Left ventricular dysfunction (Ejection Fraction<55%)
Number of participants found to have abnormal heart valve function
Time frame: At the time of screening echocardiogram
Structural heart abnormalities (valvular heart lesions classified as mild, moderate and severe)
2 secondary outcomes
Number of participants found to have adverse Maternal outcomes
Time frame: At the time of delivery
Number of participants found to have adverse Fetal outcomes
Time frame: At the time of delivery
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 30 Aug 2023.
- Derived from this study: PubMed 39817089Bhatti S, Naz S, Gurmani S, Yasmin H, Atif U, Karim M, Ahmed S, Zehra K, Hakeem A, Qamar N. Prospective Pakistan Registry of Echocardiographic Screening in Asymptomatic Pregnant Women. JACC Adv. 2024 Sep 2;3(12):101215. doi: 10.1016/j.jacadv.2024.101215. eCollection 2024 Dec.
- 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.
Sabha Bhatti, MD principal investigator
National Institute of Cardiovascular Diseases
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 Cardiovascular Diseases in Pregnancy, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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 1 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: looking for participants now, as of the sponsor's last update on 30 Aug 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 Pakistan. 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?
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 Sabha Bhatti, MD (+92 335 5554346, drsabhabhatti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants found to have abnormal left ventricular function (time frame: At the time of screening echocardiogram). The study lists 2 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 NCT06004544, 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 30 Aug 2023.