NCT04772924

Brief Summary

Patients in this prospective cohort study were selected if they had a history of PCI more than 1 year previously. 405 patients were divided based on their preferences to fasting and non fasting and after 1 month of fasting major adverse cardiovascular events were measured

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

February 19, 2021

Last Update Submit

February 25, 2021

Conditions

Coronary Artery Disease

Keywords

prolonged fastingpercutaneous coronary angioplastymajor adverse cardiac events

Outcome Measures

Primary Outcomes (1)

  • The number of participant with major adverse cardiovascular event

    1 month

Secondary Outcomes (2)

  • Dyspnea

    1 month

  • Angina based on patient report, based on Canadian heart class

    1 month

Study Arms (2)

fasting group

EXPERIMENTAL

those preferred to take long time fasting

Behavioral: fasting

non fasting

ACTIVE COMPARATOR

those preferred not to take fasting

Behavioral: not fasting

Interventions

fastingBEHAVIORAL

more than 12 hour of fasting as ceremony of Ramadan

fasting group
not fastingBEHAVIORAL

preferred not to take long term fasting

non fasting

Eligibility Criteria

Age53 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of PCI, and a minimum of 1 year between angioplasty and enrollment in this study

You may not qualify if:

  • Heart failure (ejection fraction \<50 %)
  • Advanced kidney failure (glomerular filtration rate \<60 mL/min
  • Unsuccessful revascularization
  • Coronary artery bypass graft
  • Liver cirrhosis
  • Any acute conditions such as infection
  • Needed repetitive treatment
  • Diabetes who were on insulin treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor kojuri cardiology clinic

Shiraz, Outside of the US, 55318, Iran

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCardiovascular Diseases

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple blind
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 26, 2021

Study Start

April 20, 2020

Primary Completion

May 24, 2020

Study Completion

January 1, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)